Trial Outcomes & Findings for Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery (NCT NCT02583269)

Last Updated: 2023-06-05

Results Overview

Maximum tolerable dose of muscadine grape extract is defined as the dose level immediately below the dose level that induced a dose-limiting toxicity (DLT) in \>= 2 patients, as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0DLT will be assessed by severity of adverse events.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

29 days

Results posted on

2023-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Overall Study STARTED	3	7	3	5	6
Overall Study COMPLETED	2	7	3	5	6
Overall Study NOT COMPLETED	1	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Overall Study Patient hospitalized prior to start	1	0	0	0	0

Baseline Characteristics

Muscadine Grape Skin Extract in Treating Patients With Malignancy That Is Metastatic or Cannot Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill Times a Day n=3 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills Times a Day n=7 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills Times a Day n=3 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadine Grape Skin Extract) 4 Pills Times a Day n=5 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills Times a Day n=6 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Total n=24 Participants Total of all reporting groups
Age, Continuous	81.3 years STANDARD_DEVIATION 3.29 • n=99 Participants	73.4 years STANDARD_DEVIATION 13.56 • n=107 Participants	62.6 years STANDARD_DEVIATION 6.24 • n=206 Participants	64 years STANDARD_DEVIATION 7.13 • n=7 Participants	70 years STANDARD_DEVIATION 11.8 • n=31 Participants	69.8 years STANDARD_DEVIATION 12.2 • n=30 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	3 Participants n=107 Participants	2 Participants n=206 Participants	3 Participants n=7 Participants	2 Participants n=31 Participants	10 Participants n=30 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	4 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants	4 Participants n=31 Participants	14 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=99 Participants	7 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=7 Participants	6 Participants n=31 Participants	24 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants
Race (NIH/OMB) White	2 Participants n=99 Participants	7 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=7 Participants	6 Participants n=31 Participants	23 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Region of Enrollment United States	3 participants n=99 Participants	7 participants n=107 Participants	3 participants n=206 Participants	5 participants n=7 Participants	6 participants n=31 Participants	24 participants n=30 Participants

PRIMARY outcome

Timeframe: 29 days

Population: As pre-specified in the protocol, data collection and analysis for all arms will be combined. MTD was not determined, as there was not a dose level with ≥2 dose limiting toxicities (DLT). One DLT at dose level 2 and therefore 3 additional participants were enrolled. No subsequent DLTs and the study was stopped at dose level 5, per protocol.

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=3 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day n=7 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day n=3 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day n=5 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day n=6 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Number of Participants With Dose-Limiting Toxicity	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: As pre-specified in the protocol, this study is not intended to be analyzed by arm for most analyses and data collection. Analysis for all arms will be combined for Adherence to EMG treatment.

Pill count will be calculated from counting the number of pills returned as well as by summarizing the patient's pill diary. The percent of pills taken will be summarized by dose level using the median and 95% confidence interval. Investigators will summarize the percent of pills taken at the end of every 4 week period i using the formula: Percent of pills taken)i = (Dose Level ×7 ×4)i minus Pill Count divided by Dose Level ×7 ×4)i

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=19 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Adherence to MGE Treatment, as Measured by Percent of Pills Taken at the End of Every 4 Week Period	97.8 percentage of pills Interval 95.8 to 99.4	—	—	—	—

SECONDARY outcome

Timeframe: At the end of treatment, up to 1 year

Population: As pre-specified in the protocol, this study is not intended to be analyzed by arm for most analyses and data collection. Analysis for all arms will be combined for Best Response

Best response will be characterized using a frequency table. Evaluation of new or enlarging effusions to differentiate between Progressive Disease and Response/Stable Disease. Measurements will be obtained from usual care imaging and assessed by the principal investigators in confirmation with the physician of record. Clinical lesions will only be considered measurable when they are superficial and ≥10 mm in diameter as assessed using calipers. For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion, is recommended.

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=16 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Best Response Stable Disease	8 Participants	—	—	—	—
Best Response Progressive Disease	8 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=19 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Change in Total Phenolic Levels in Blood Baseline	2123.8 ug/ml Standard Error 69.1	—	—	—	—
Change in Total Phenolic Levels in Blood Week 4	2049.3 ug/ml Standard Error 69.1	—	—	—	—
Change in Total Phenolic Levels in Blood Week 8	2308.1 ug/ml Standard Error 71.7	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: Arms were combined for cytokine and phenolic analyses as pre-specified per protocol

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=19 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Change in Total Phenolic Levels in Urine Baseline	1107.2 ug/ml Standard Error 142.4	—	—	—	—
Change in Total Phenolic Levels in Urine Week 4	1024.5 ug/ml Standard Error 142.3	—	—	—	—
Change in Total Phenolic Levels in Urine Week 8	1274.6 ug/ml Standard Error 150.7	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to up to 1 year

Population: As pre-specified in the protocol, this study is not intended to be analyzed by arm for most analyses and data collection. Analysis for all arms will be combined for change in quality of life. All participants did not complete intervention for outcome measures are various time points (i.e., week 4 and week 8)

A mixed model ANOVA model will be fit with phenolic level as the outcome and time (baseline, every 4 weeks) as a fixed effect and subject as a random effect. Contrasts will be use to estimate changes from baseline to each follow-up time period. Score scales from 0 (not at all) to 4 (very much). Sum of scores range 0-28 for social, functional and physical well being and 0-24 for emotional well being and multiplied by 6. All four scores are totaled with a score range of 0-108. A mean of the combined group scores will be used. A higher score indicates a higher worse outcome of the illness on the participant.

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=21 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G FACT-G Overall Score - at Baseline	80.6 score on a scale Standard Error 3.9	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G Fact G - Overall Score - at Week 4	79.4 score on a scale Standard Error 3.9	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G Fact G - Overall Score - at Week 8	81.1 score on a scale Standard Error 4.0	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G Functional well being - at Baseline	17.7 score on a scale Standard Error 1.6	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G Functional well being - at Week 4	17.7 score on a scale Standard Error 1.6	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G Functional well being - at Week 8	16.5 score on a scale Standard Error 1.7	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G Emotional Well being - at Baseline	17.8 score on a scale Standard Error 0.9	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G Emotional well being - at Week 4	17.8 score on a scale Standard Error 0.9	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G Emotional well being - at Week 8	18.8 score on a scale Standard Error 1.0	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G Physical well being - at Baseline	20.6 score on a scale Standard Error 1.5	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G Physical well being - at Week 4	19.3 score on a scale Standard Error 1.5	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G Physical well being - at Week 8	20.4 score on a scale Standard Error 1.6	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G Social well being - at Baseline	24.5 score on a scale Standard Error 0.7	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G Social well being - at Week 4	24.9 score on a scale Standard Error 0.7	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G Social well being - at Week 8	25.4 score on a scale Standard Error 0.8	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: Arms were combined for cytokine and phenolic analyses as pre-specified per protocol

A mixed model ANOVA model will fit with the outcome of interest (cytokine or growth factor) as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=19 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Change in Systemic Cytokine Levels Week 8 TNF alpha	4.97 pg/mL Standard Error 0.41	—	—	—	—
Change in Systemic Cytokine Levels Baseline to Week 8 IL-1 alpha	NA pg/mL Standard Error NA All values below lower limit of detection - could not be analyzed	—	—	—	—
Change in Systemic Cytokine Levels Baseline to 8 weeks IL-1 beta	NA pg/mL Standard Error NA 70% of values below lower limit of detection - could not be analyzed	—	—	—	—
Change in Systemic Cytokine Levels Baseline to 8 weeks IL-6	NA pg/mL Standard Error NA 85% of values below lower limit of detection - could not be analyzed	—	—	—	—
Change in Systemic Cytokine Levels Baseline TNF alpha	4.74 pg/mL Standard Error 0.39	—	—	—	—
Change in Systemic Cytokine Levels Week 4 TNF alpha	4.95 pg/mL Standard Error 0.39	—	—	—	—
Change in Systemic Cytokine Levels Baseline IL-6R	10905.9 pg/mL Standard Error 1013.7	—	—	—	—
Change in Systemic Cytokine Levels Week 4 IL-6R	11111.7 pg/mL Standard Error 993.7	—	—	—	—
Change in Systemic Cytokine Levels Week 8 IL-6R	12402.9 pg/mL Standard Error 1077.9	—	—	—	—

SECONDARY outcome

Timeframe: Up to 1 year

AEs/toxicity will be assessed at weeks 4, 8 and every 4 weeks thereafter if patients remain on treatment. Any expected toxicities, any laboratory based toxicities, and any grade 3 or higher gastrointestinal toxicities, and any grade 4 or higher toxicities will be summarized using frequency tables overall and by week.

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=3 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day n=6 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day n=3 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day n=3 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day n=6 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Incidence of Adverse Events (AEs), Assessed Using NCI CTCAE Version 4.0	3 Participants	3 Participants	2 Participants	2 Participants	5 Participants

SECONDARY outcome

Timeframe: At 8 weeks

Population: As pre-specified in the protocol, data will be collected and analyzed for all arms combined. At 8 weeks, only 16 patients were evaluable.

Response will be characterized using a frequency table.

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=16 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Overall Response Rate of MGE (Complete Response, Partial Response, and Stable Disease) Stable Disease	8 Participants	—	—	—	—
Overall Response Rate of MGE (Complete Response, Partial Response, and Stable Disease) Progressive Disease	8 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to 4 years

Population: As pre-specified in the protocol, this study is not intended to be analyzed by arm for most analyses and data collection. Analysis for all arms will be combined for overall survival.

OS will summarized using the Kaplan-Meier method. Median survival rates and associated 95% confidence intervals will be calculated.

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=21 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Overall Survival (OS)	7.2 months Interval 4.4 to 13.7	—	—	—	—

SECONDARY outcome

Timeframe: Up to 4 years

Population: As pre-specified in the protocol, this study is not intended to be analyzed by arm for most analyses and data collection. Analysis for all arms will be combined for progression free survival.

PFS will summarized using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=21 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Progression-free Survival (PFS)	3.0 months Interval 1.8 to 4.9	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=20 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Change in Component Phenolic Levels in Urine Baseline	0.4 ug/ml Standard Error 7.9	—	—	—	—
Change in Component Phenolic Levels in Urine Week 4	19.7 ug/ml Standard Error 8.2	—	—	—	—
Change in Component Phenolic Levels in Urine Week 8	16.6 ug/ml Standard Error 8.6	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: Outcome measure was not measured

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to 1 year

Population: As pre-specified in the protocol, this study is not intended to be analyzed by arm for most analyses and data collection. Analysis for all arms will be combined for change in quality of life. Not all participants completed intervention at the week 4 and week 8 time frames to be analyzed

A mixed model ANOVA model will be fit with phenolic level as the outcome and time (baseline, every 4 weeks) as a fixed effect and subject as a random effect. Contrasts will be use to estimate changes from baseline to each follow-up time period. A 6-item questionnaire with T-score responses ranging from a minimum of 33.4 to a maximum of 76.8. Higher scores equals more of the concept being measured.

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=21 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by PROMIS-Fatigue SF Baseline	56.2 T-score Standard Error 2.5	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by PROMIS-Fatigue SF Week 4	57.3 T-score Standard Error 2.6	—	—	—	—
Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by PROMIS-Fatigue SF Week 8	55.3 T-score Standard Error 2.7	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: Arms were combined for cytokine and phenolic analyses as pre-specified per protocol

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=19 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Change in Systemic Cytokine Levels (Log IL-8) Baseline Log IL-8	1.49 log pg/mL Standard Error 0.16	—	—	—	—
Change in Systemic Cytokine Levels (Log IL-8) Week 4 Log IL-8	1.32 log pg/mL Standard Error 0.17	—	—	—	—
Change in Systemic Cytokine Levels (Log IL-8) Week 8 Log IL-8	1.40 log pg/mL Standard Error 0.17	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to up to 8 weeks

Population: Arms were combined for cytokine and phenolic analyses as pre-specified per protocol

Outcome measures

Outcome measures
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill 2 Times Per Day n=19 Participants Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 4 (Muscadline Grape Skin Extract) 4 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 5 (Muscadine Grape Skin Extract) 5 Pills 2 Times a Day Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies
Change in Systemic Cytokine Levels (Log VEGF) Baseline Log VEGF	2.78 log pg/mL Standard Error 0.23	—	—	—	—
Change in Systemic Cytokine Levels (Log VEGF) Week 4 Log VEGF	2.81 log pg/mL Standard Error 0.23	—	—	—	—
Change in Systemic Cytokine Levels (Log VEGF) Week 8 Log VEGF	2.84 log pg/mL Standard Error 0.23	—	—	—	—

Adverse Events

Arm 1 (Muscadine Grape Skin Extract) 1 Pill Times a Day

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 2 (Muscadine Grape Skin Extract) 2 Pills Times a Day

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Arm 3 (Muscadine Grape Skin Extract) 3 Pills Times a Day

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 4 (Muscadine Grape Skin Extract) 4 Pills Times a Day

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 5 (Muscadine Grape Skin Extract) 5 Pills Times a Day

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill Times a Day n=3 participants at risk Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills Times a Day n=6 participants at risk Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills Times a Day n=3 participants at risk Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO	Arm 4 (Muscadine Grape Skin Extract) 4 Pills Times a Day n=3 participants at risk Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO	Arm 5 (Muscadine Grape Skin Extract) 5 Pills Times a Day n=6 participants at risk Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO
General disorders Sudden death, not otherwise specified	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Infections and infestations Lung infection	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Vascular disorders Thromboembolic event	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year

Other adverse events

Other adverse events
Measure	Arm 1 (Muscadine Grape Skin Extract) 1 Pill Times a Day n=3 participants at risk Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 2 (Muscadine Grape Skin Extract) 2 Pills Times a Day n=6 participants at risk Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO Quality-of-Life Assessment: Ancillary studies	Arm 3 (Muscadine Grape Skin Extract) 3 Pills Times a Day n=3 participants at risk Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO	Arm 4 (Muscadine Grape Skin Extract) 4 Pills Times a Day n=3 participants at risk Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO	Arm 5 (Muscadine Grape Skin Extract) 5 Pills Times a Day n=6 participants at risk Patients receive muscadine grape skin extract PO BID. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing benefit from muscadine grape skin extract may continue treatment in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Muscadine Grape Skin Extract: Given PO
Blood and lymphatic system disorders Anemia	100.0% 3/3 • Number of events 3 • One year	50.0% 3/6 • Number of events 3 • One year	66.7% 2/3 • Number of events 2 • One year	66.7% 2/3 • Number of events 2 • One year	83.3% 5/6 • Number of events 5 • One year
Eye disorders Eye disorders	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year
Gastrointestinal disorders Abdominal pain	33.3% 1/3 • Number of events 1 • One year	50.0% 3/6 • Number of events 3 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Gastrointestinal disorders Ascites	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • One year	33.3% 2/6 • Number of events 2 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Gastrointestinal disorders Diarrhea	0.00% 0/3 • One year	50.0% 3/6 • Number of events 3 • One year	0.00% 0/3 • One year	33.3% 1/3 • Number of events 1 • One year	16.7% 1/6 • Number of events 1 • One year
Gastrointestinal disorders Dry mouth	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	33.3% 2/6 • Number of events 2 • One year
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • Number of events 1 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Gastrointestinal disorders Flatulence	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	33.3% 1/3 • Number of events 1 • One year	83.3% 5/6 • Number of events 5 • One year
Gastrointestinal disorders Nausea	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year
Gastrointestinal disorders Vomiting	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year
General disorders Chills	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
General disorders Edema, face	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year
General disorders Edema, limbs	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
General disorders Fatigue	33.3% 1/3 • Number of events 1 • One year	66.7% 4/6 • Number of events 4 • One year	33.3% 1/3 • Number of events 1 • One year	66.7% 2/3 • Number of events 2 • One year	16.7% 1/6 • Number of events 1 • One year
General disorders Gait disturbance	0.00% 0/3 • One year	0.00% 0/6 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
General disorders General disorders and administration site conditions, other	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Infections and infestations Mucosal infection	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Infections and infestations Urinary tract infection	0.00% 0/3 • One year	0.00% 0/6 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/3 • One year	33.3% 2/6 • Number of events 2 • One year
Investigations Alkaline phosphatase increased	33.3% 1/3 • Number of events 1 • One year	33.3% 2/6 • Number of events 2 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	33.3% 2/6 • Number of events 2 • One year
Investigations Aspartate aminotransferase increased	0.00% 0/3 • One year	33.3% 2/6 • Number of events 2 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Investigations Blood bilirubin increased	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Investigations Creatinine increased	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Investigations Lymphocyte count decreased	66.7% 2/3 • Number of events 2 • One year	16.7% 1/6 • Number of events 1 • One year	100.0% 3/3 • Number of events 3 • One year	66.7% 2/3 • Number of events 2 • One year	50.0% 3/6 • Number of events 3 • One year
Investigations Platelet count decreased	0.00% 0/3 • One year	0.00% 0/6 • One year	33.3% 1/3 • Number of events 1 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year
Metabolism and nutrition disorders Weight loss	33.3% 1/3 • Number of events 1 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year
Investigations White blood cell decreased	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Metabolism and nutrition disorders Hyperglycemia	100.0% 3/3 • Number of events 3 • One year	50.0% 3/6 • Number of events 3 • One year	66.7% 2/3 • Number of events 2 • One year	66.7% 2/3 • Number of events 2 • One year	66.7% 4/6 • Number of events 4 • One year
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • Number of events 1 • One year	50.0% 3/6 • Number of events 3 • One year	33.3% 1/3 • Number of events 1 • One year	33.3% 1/3 • Number of events 1 • One year	50.0% 3/6 • Number of events 3 • One year
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/3 • One year	0.00% 0/6 • One year	33.3% 1/3 • Number of events 1 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • One year	33.3% 2/6 • Number of events 2 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Metabolism and nutrition disorders Hyponatremia	66.7% 2/3 • Number of events 2 • One year	33.3% 2/6 • Number of events 2 • One year	66.7% 2/3 • Number of events 2 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Number of events 1 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue, other	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Number of events 1 • One year	16.7% 1/6 • Number of events 1 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Nervous system disorders Dysgeusia	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year
Psychiatric disorders Agitation	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Psychiatric disorders Anxiety	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Psychiatric disorders Delusions	0.00% 0/3 • One year	0.00% 0/6 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Renal and urinary disorders Chronic kidney disease	33.3% 1/3 • Number of events 1 • One year	16.7% 1/6 • Number of events 1 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/3 • One year	33.3% 2/6 • Number of events 2 • One year
Renal and urinary disorders Hematuria	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • One year	0.00% 0/6 • One year	33.3% 1/3 • Number of events 1 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year
Respiratory, thoracic and mediastinal disorders Nasal congestion	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • One year	0.00% 0/6 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Skin and subcutaneous tissue disorders Hyperhidrosis	33.3% 1/3 • Number of events 1 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Vascular disorders Hypotension	0.00% 0/3 • One year	0.00% 0/6 • One year	33.3% 1/3 • Number of events 1 • One year	0.00% 0/3 • One year	0.00% 0/6 • One year
Vascular disorders Thromboembolic event	0.00% 0/3 • One year	0.00% 0/6 • One year	0.00% 0/3 • One year	0.00% 0/3 • One year	16.7% 1/6 • Number of events 1 • One year

Additional Information

Study Nurse

Wake Forest University Health Sciences

Phone: 336-713-7748

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place