Trial Outcomes & Findings for Hypomethylating Properties of Freeze-dried Black Raspberries (BRB) in Patients With Myelodysplastic Syndrome or Myelodysplastic Syndrome/Myeloproliferative Neoplasm (MDS/MPN) (NCT NCT03140280)

Last Updated: 2022-11-04

Results Overview

Adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; patients will be evaluated every four weeks for toxicity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Up to 52 weeks

Results posted on

2022-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	Dietary Intervention Freeze-dried black raspberry powder administration. Freeze-Dried Black Raspberry Powder: 25 gm (2x/day) of freeze-dried black raspberry powder taken orally in 8 ounces of water for 12 weeks. If the patient is tolerating BRBs well and is benefiting from therapy, he or she will continue treatment for a total maximum of 48 weeks.
Overall Study STARTED	23
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Dietary Intervention Freeze-dried black raspberry powder administration. Freeze-Dried Black Raspberry Powder: 25 gm (2x/day) of freeze-dried black raspberry powder taken orally in 8 ounces of water for 12 weeks. If the patient is tolerating BRBs well and is benefiting from therapy, he or she will continue treatment for a total maximum of 48 weeks.
Overall Study Physician Decision	5

Baseline Characteristics

Hypomethylating Properties of Freeze-dried Black Raspberries (BRB) in Patients With Myelodysplastic Syndrome or Myelodysplastic Syndrome/Myeloproliferative Neoplasm (MDS/MPN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dietary Intervention n=18 Participants Freeze-dried black raspberry powder administration. Freeze-Dried Black Raspberry Powder: 25 gm (2x/day) of freeze-dried black raspberry powder taken orally in 8 ounces of water for 12 weeks. If the patient is tolerating BRBs well and is benefiting from therapy, he or she will continue treatment for a total maximum of 48 weeks.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=99 Participants
Age, Categorical >=65 years	12 Participants n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	16 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	18 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; patients will be evaluated every four weeks for toxicity.

Outcome measures

Outcome measures
Measure	Dietary Intervention n=18 Participants Freeze-dried black raspberry powder administration. Freeze-Dried Black Raspberry Powder: 25 gm (2x/day) of freeze-dried black raspberry powder taken orally in 8 ounces of water for 12 weeks. If the patient is tolerating BRBs well and is benefiting from therapy, he or she will continue treatment for a total maximum of 48 weeks.
The Number of Patients With Grade 3 or Higher Serious Adverse Events.	3 Participants

SECONDARY outcome

Timeframe: Up to 52 Weeks

The subject's best clinical response will be assessed based on the modified International Working Group response criteria while receiving BRBs.

Outcome measures

Outcome measures
Measure	Dietary Intervention n=18 Participants Freeze-dried black raspberry powder administration. Freeze-Dried Black Raspberry Powder: 25 gm (2x/day) of freeze-dried black raspberry powder taken orally in 8 ounces of water for 12 weeks. If the patient is tolerating BRBs well and is benefiting from therapy, he or she will continue treatment for a total maximum of 48 weeks.
The Number of Subjects Showing a Response.	0 Participants

Adverse Events

Dietary Intervention

Serious events: 4 serious events

Other events: 18 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Dietary Intervention n=18 participants at risk Freeze-dried black raspberry powder administration. Freeze-Dried Black Raspberry Powder: 25 gm (2x/day) of freeze-dried black raspberry powder taken orally in 8 ounces of water for 12 weeks. If the patient is tolerating BRBs well and is benefiting from therapy, he or she will continue treatment for a total maximum of 48 weeks.
Nervous system disorders Syncope	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Immune system disorders Allergic Reaction	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
General disorders Death not otherwise specified	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.

Other adverse events

Other adverse events
Measure	Dietary Intervention n=18 participants at risk Freeze-dried black raspberry powder administration. Freeze-Dried Black Raspberry Powder: 25 gm (2x/day) of freeze-dried black raspberry powder taken orally in 8 ounces of water for 12 weeks. If the patient is tolerating BRBs well and is benefiting from therapy, he or she will continue treatment for a total maximum of 48 weeks.
Gastrointestinal disorders Abdominal pain	16.7% 3/18 • Number of events 3 • 52 weeks This measure reports serious adverse events regardless of grade.
Investigations Alanine transaminase increased	11.1% 2/18 • Number of events 2 • 52 weeks This measure reports serious adverse events regardless of grade.
Investigations alkaline phosphatase increased	16.7% 3/18 • Number of events 4 • 52 weeks This measure reports serious adverse events regardless of grade.
Metabolism and nutrition disorders Alkalosis	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Blood and lymphatic system disorders Anemia	16.7% 3/18 • Number of events 6 • 52 weeks This measure reports serious adverse events regardless of grade.
Investigations Aspartate transferase increase	11.1% 2/18 • Number of events 3 • 52 weeks This measure reports serious adverse events regardless of grade.
Gastrointestinal disorders Bloating	16.7% 3/18 • Number of events 3 • 52 weeks This measure reports serious adverse events regardless of grade.
Investigations Blood bilirubin increase	16.7% 3/18 • Number of events 3 • 52 weeks This measure reports serious adverse events regardless of grade.
Injury, poisoning and procedural complications Bruising	22.2% 4/18 • Number of events 5 • 52 weeks This measure reports serious adverse events regardless of grade.
General disorders Chills	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Psychiatric disorders Confusion	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Gastrointestinal disorders Constipation	33.3% 6/18 • Number of events 7 • 52 weeks This measure reports serious adverse events regardless of grade.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Investigations Creatinine increased	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Psychiatric disorders Depression	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Gastrointestinal disorders Diarrhea	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Nervous system disorders Dizziness	16.7% 3/18 • Number of events 3 • 52 weeks This measure reports serious adverse events regardless of grade.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 3/18 • Number of events 3 • 52 weeks This measure reports serious adverse events regardless of grade.
General disorders Fatigue	27.8% 5/18 • Number of events 6 • 52 weeks This measure reports serious adverse events regardless of grade.
Gastrointestinal disorders Flatulence	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Injury, poisoning and procedural complications Fracture	5.6% 1/18 • Number of events 2 • 52 weeks This measure reports serious adverse events regardless of grade.
Gastrointestinal disorders Gastrointestional disorders other, specify	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Nervous system disorders Headache	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Vascular disorders Hematoma	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Renal and urinary disorders Hematuria	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Hepatobiliary disorders Hepatobiliary disorders, specify	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Metabolism and nutrition disorders Hyperglycemia	33.3% 6/18 • Number of events 12 • 52 weeks This measure reports serious adverse events regardless of grade.
Metabolism and nutrition disorders Hyperkalemia	11.1% 2/18 • Number of events 3 • 52 weeks This measure reports serious adverse events regardless of grade.
Metabolism and nutrition disorders Hypermagnasemia	5.6% 1/18 • Number of events 2 • 52 weeks This measure reports serious adverse events regardless of grade.
Vascular disorders Hypertension	22.2% 4/18 • Number of events 5 • 52 weeks This measure reports serious adverse events regardless of grade.
Metabolism and nutrition disorders Hyperuricemia	22.2% 4/18 • Number of events 4 • 52 weeks This measure reports serious adverse events regardless of grade.
Metabolism and nutrition disorders Hypoalbuminemia	22.2% 4/18 • Number of events 5 • 52 weeks This measure reports serious adverse events regardless of grade.
Metabolism and nutrition disorders Hypocalcemia	11.1% 2/18 • Number of events 2 • 52 weeks This measure reports serious adverse events regardless of grade.
Metabolism and nutrition disorders Hypoglycemia	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Metabolism and nutrition disorders Hypomagnesemia	5.6% 1/18 • Number of events 2 • 52 weeks This measure reports serious adverse events regardless of grade.
Metabolism and nutrition disorders Hyponatremia	22.2% 4/18 • Number of events 4 • 52 weeks This measure reports serious adverse events regardless of grade.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Infections and infestations Infections and infestations, other, specify	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications, other, specify	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Psychiatric disorders Insomnia	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Investigations Investigations, other, specify	11.1% 2/18 • Number of events 2 • 52 weeks This measure reports serious adverse events regardless of grade.
Vascular disorders Lymphedema	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Investigations Lymphocyte count decreased	33.3% 6/18 • Number of events 12 • 52 weeks This measure reports serious adverse events regardless of grade.
Metabolism and nutrition disorders Metabolism and nutrition disorders, others, specify	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Respiratory, thoracic and mediastinal disorders Nasal congestion	16.7% 3/18 • Number of events 3 • 52 weeks This measure reports serious adverse events regardless of grade.
Gastrointestinal disorders Nausea	11.1% 2/18 • Number of events 2 • 52 weeks This measure reports serious adverse events regardless of grade.
Musculoskeletal and connective tissue disorders Neck pain	11.1% 2/18 • Number of events 2 • 52 weeks This measure reports serious adverse events regardless of grade.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps), other, specify	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Investigations Neutrophil count decreased	50.0% 9/18 • Number of events 19 • 52 weeks This measure reports serious adverse events regardless of grade.
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 2/18 • Number of events 2 • 52 weeks This measure reports serious adverse events regardless of grade.
Nervous system disorders Paresthesia	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Investigations Platlet count decrease	27.8% 5/18 • Number of events 13 • 52 weeks This measure reports serious adverse events regardless of grade.
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.1% 2/18 • Number of events 2 • 52 weeks This measure reports serious adverse events regardless of grade.
Respiratory, thoracic and mediastinal disorders Productive cough	16.7% 3/18 • Number of events 3 • 52 weeks This measure reports serious adverse events regardless of grade.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders, other, specify	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Cardiac disorders Sinus bradycardia	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders, other, specify	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Skin and subcutaneous tissue disorders Skin ulceration	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Respiratory, thoracic and mediastinal disorders Sore throat	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Gastrointestinal disorders Stomach pain	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Nervous system disorders Syncope	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Infections and infestations Upper respiratory infection	11.1% 2/18 • Number of events 2 • 52 weeks This measure reports serious adverse events regardless of grade.
Infections and infestations Urinary tract infection	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Gastrointestinal disorders Vomiting	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
Investigations White blood cell count decreased	38.9% 7/18 • Number of events 17 • 52 weeks This measure reports serious adverse events regardless of grade.
General disorders Edema limbs	11.1% 2/18 • Number of events 3 • 52 weeks This measure reports serious adverse events regardless of grade.
Gastrointestinal disorders Intra-abdominal hemmorrhage	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.
General disorders Localized edema	11.1% 2/18 • Number of events 3 • 52 weeks This measure reports serious adverse events regardless of grade.
General disorders Non-cardiac chest pain	11.1% 2/18 • Number of events 2 • 52 weeks This measure reports serious adverse events regardless of grade.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.6% 1/18 • Number of events 1 • 52 weeks This measure reports serious adverse events regardless of grade.

Additional Information

Ehab Atallah, MD

Medical College of Wisconsin

Phone: 414-805-4600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place