Phase 2
Completed N=120
Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients
Source: ClinicalTrials.gov NCT01906008 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Average Area Under the Curve (AUC) for Numbness/Tingling Over 4 Months — 35.4; 31.5 Units on a scale *days
Summary
The goal of this clinical research study is to learn if minocycline can reduce numbness, pain, and/or loss of motor function in patients with colorectal cancer. In this study, minocycline will be compared to a placebo.
The study doctor can explain how the study drug is designed to work.
A placebo is not a drug. It looks like the study drug, but it is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Area Under the Curve (AUC) for Numbness/Tingling Over 4 Months |
35.4; 31.5 | — |
| SECONDARY Average Area Under the Curve (AUC) for Fatigue Over 4 Months |
47.92; 40.31 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with a pathologically proven diagnosis of CRC seen either at MD Anderson or LBJ.
- Patients > or = 18 years old.
- Patients who qualify for oxaliplatin-based chemotherapy (in the adjuvant or metastatic setting) and are likely to receive at least 3 months of oxaliplatin.
- Patients who speak English or Spanish (due to language options for the MDASI version being used in this study, we are only recruiting English-speaking or Spanish-speaking patients).
- Patients with an NCI-CTCv4 sensory neuropathy score of 0.
- Patients with adequate renal function (serum creatinine must be 40 (Obese Class III criteria).
- Patients who will receive cetuximab or other targeted therapy where physicians may use topical doxycycline to reduce the rash associated with therapy.
Data sourced from ClinicalTrials.gov (NCT01906008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.