Trial Outcomes & Findings for Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients (NCT NCT01906008)
NCT ID: NCT01906008
Last Updated: 2020-03-17
Results Overview
AUC for MDASI-numbness/tingling . Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference. For this study, the sub scale is the average of the 2 preselected items namely, numbness/tingling and fatigue. This subscale ranges from 0 to 10. The primary outcome is the average of the 120 -day area (4 months) under the curve for the sub scale. AUC ranges from 0 (0\*120) to 1200 (10\*120). To put this into perspective, the average AUC of 103.5 can also be thought of as an average daily AUC of 0.86 ( 103.5/120) on a 0 to 10 scale over the 120-day study period. Lower values represent better outcome while higher values represent worse outcome.
COMPLETED
PHASE2
122 participants
Baseline to 4 months
2020-03-17
Participant Flow
Recruitment period: November 25, 2013 to May, 25 2017. Recruitment done at the University of Texas MD Anderson Cancer and LBJ.
Of the 122 participants enrolled 2 participant were excluded from the study before asssigment to groups.
Participant milestones
| Measure |
Minocycline
Minocycline 100 mg twice a day during 4 months
|
Placebo
Placebo 100 mg twice a day during 4 months
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
61
|
|
Overall Study
COMPLETED
|
32
|
34
|
|
Overall Study
NOT COMPLETED
|
27
|
27
|
Reasons for withdrawal
| Measure |
Minocycline
Minocycline 100 mg twice a day during 4 months
|
Placebo
Placebo 100 mg twice a day during 4 months
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Oxaliplatin toxicity
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
Did not start study med
|
3
|
4
|
|
Overall Study
Oxaliplatin stops
|
10
|
8
|
|
Overall Study
Hospice
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
3
|
|
Overall Study
Lack of compliance of study med
|
5
|
3
|
|
Overall Study
Adverse Event
|
0
|
3
|
Baseline Characteristics
Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients
Baseline characteristics by cohort
| Measure |
Minocycline
n=32 Participants
Minocycline 100 mg twice a day during 4 months
|
Placebo
n=34 Participants
Placebo 100 mg twice a day during 4 months
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Continuous
|
53.4 Years
STANDARD_DEVIATION 10.1 • n=99 Participants
|
51.4 Years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
52.4 Years
STANDARD_DEVIATION 10.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=99 Participants
|
34 participants
n=107 Participants
|
66 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 monthsAUC for MDASI-numbness/tingling . Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference. For this study, the sub scale is the average of the 2 preselected items namely, numbness/tingling and fatigue. This subscale ranges from 0 to 10. The primary outcome is the average of the 120 -day area (4 months) under the curve for the sub scale. AUC ranges from 0 (0\*120) to 1200 (10\*120). To put this into perspective, the average AUC of 103.5 can also be thought of as an average daily AUC of 0.86 ( 103.5/120) on a 0 to 10 scale over the 120-day study period. Lower values represent better outcome while higher values represent worse outcome.
Outcome measures
| Measure |
Minocycline
n=32 Participants
Minocycline 100 mg twice a day during 4 months
|
Placebo
n=34 Participants
Placebo 100 mg twice a day during 4 months
|
|---|---|---|
|
Average Area Under the Curve (AUC) for Numbness/Tingling Over 4 Months
|
35.4 Units on a scale *days
Standard Deviation 27.35
|
31.5 Units on a scale *days
Standard Deviation 27.8
|
SECONDARY outcome
Timeframe: Baseline to 4 monthsAUC for MDASI-fatigue . Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference. For this study, the sub scale is the average of the 2 preselected items namely, numbness/tingling and fatigue. This subscale ranges from 0 to 10. The primary outcome is the average of the 120 -day area (4 months) under the curve for the sub scale. AUC ranges from 0 (0\*120) to 1200 (10\*120). To put this into perspective, the average AUC of 103.5 can also be thought of as an average daily AUC of 0.86 ( 103.5/120) on a 0 to 10 scale over the 120-day study period. Lower values represent better outcome while higher values represent worse outcome.
Outcome measures
| Measure |
Minocycline
n=32 Participants
Minocycline 100 mg twice a day during 4 months
|
Placebo
n=34 Participants
Placebo 100 mg twice a day during 4 months
|
|---|---|---|
|
Average Area Under the Curve (AUC) for Fatigue Over 4 Months
|
47.92 Units on a scale *days
Standard Deviation 36.42
|
40.31 Units on a scale *days
Standard Deviation 30.92
|
Adverse Events
Minocycline
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Minocycline
n=32 participants at risk
Minocycline 100 mg twice a day during 4 months
|
Placebo
n=34 participants at risk
Placebo 100 mg twice a day during 4 months
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Hiperpigmentation spots
|
3.1%
1/32 • The adverse events were monitoring/assessed from the first dose of study medication, up to 30 days after the last dose.
|
0.00%
0/34 • The adverse events were monitoring/assessed from the first dose of study medication, up to 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Elevated LFT's
|
3.1%
1/32 • The adverse events were monitoring/assessed from the first dose of study medication, up to 30 days after the last dose.
|
0.00%
0/34 • The adverse events were monitoring/assessed from the first dose of study medication, up to 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Elevated ALT
|
0.00%
0/32 • The adverse events were monitoring/assessed from the first dose of study medication, up to 30 days after the last dose.
|
2.9%
1/34 • The adverse events were monitoring/assessed from the first dose of study medication, up to 30 days after the last dose.
|
|
Metabolism and nutrition disorders
Elevated total Bilirrubin
|
0.00%
0/32 • The adverse events were monitoring/assessed from the first dose of study medication, up to 30 days after the last dose.
|
2.9%
1/34 • The adverse events were monitoring/assessed from the first dose of study medication, up to 30 days after the last dose.
|
Additional Information
Dr. James Yao, MD, Director of GI Medical Oncology
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place