Trial · NCT01906008
Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients
NCT01906008, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients. Trials, record NCT01906008. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01906008
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients
- NCT number
- NCT01906008
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 122 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Colorectal Cancer
- Interventions
- Minocycline, Placebo, Questionnaires, Sensory Test
- First posted
- 2013-07-23
- Last updated
- 2020-03-17
- Results first posted
- 2020-03-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Area Under the Curve (AUC) for Numbness/Tingling Over 4 Months | Baseline to 4 months | 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. |
| Secondary | Average Area Under the Curve (AUC) for Fatigue Over 4 Months | Baseline to 4 months | AUC 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Area Under the Curve (AUC) for Numbness/Tingling Over 4 Months | Baseline to 4 months | Units on a scale *days | MEAN | |
| SECONDARY | Average Area Under the Curve (AUC) for Fatigue Over 4 Months | Baseline to 4 months | Units on a scale *days | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Area Under the Curve (AUC) for Numbness/Tingling Over 4 Months | Minocycline | 35.4 | Standard Deviation 27.35 | Units on a scale *days | |
| Average Area Under the Curve (AUC) for Numbness/Tingling Over 4 Months | Placebo | 31.5 | Standard Deviation 27.8 | Units on a scale *days | |
| Average Area Under the Curve (AUC) for Fatigue Over 4 Months | Minocycline | 47.92 | Standard Deviation 36.42 | Units on a scale *days | |
| Average Area Under the Curve (AUC) for Fatigue Over 4 Months | Placebo | 40.31 | Standard Deviation 30.92 | Units on a scale *days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Minocycline | 59 | |
| Overall Study | STARTED | Placebo | 61 | |
| Overall Study | COMPLETED | Minocycline | 32 | |
| Overall Study | COMPLETED | Placebo | 34 | |
| Overall Study | NOT COMPLETED | Minocycline | 27 | |
| Overall Study | NOT COMPLETED | Placebo | 27 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hiperpigmentation spots | Skin and subcutaneous tissue disorders | Minocycline | 1 | 32 | |
| other | Hiperpigmentation spots | Skin and subcutaneous tissue disorders | Placebo | 0 | 34 | |
| other | Elevated LFT's | Metabolism and nutrition disorders | Minocycline | 1 | 32 | |
| other | Elevated LFT's | Metabolism and nutrition disorders | Placebo | 0 | 34 | |
| other | Elevated ALT | Metabolism and nutrition disorders | Minocycline | 0 | 32 | |
| other | Elevated ALT | Metabolism and nutrition disorders | Placebo | 1 | 34 | |
| other | Elevated total Bilirrubin | Metabolism and nutrition disorders | Minocycline | 0 | 32 | |
| other | Elevated total Bilirrubin | Metabolism and nutrition disorders | Placebo | 1 | 34 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Minocycline | 0 | 32 |
| Total, all-cause mortality | Placebo | 0 | 34 |
| Total, other adverse events | Minocycline | 2 | 32 |
| Total, other adverse events | Placebo | 2 | 34 |
| Total, serious adverse events | Minocycline | 0 | 32 |
| Total, serious adverse events | Placebo | 0 | 34 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Minocycline vs Placebo: deaths from any cause | Trial comparisons |
| Minocycline vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01906008
GET https://conductscience.org/api/trials/v1/NCT01906008/registered