MedTrace Logo

Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients

NCT01906008 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2020-03-17

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Minocycline

200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for 4 months beginning at chemotherapy initiation.

DRUG

Placebo

1 placebo by mouth for the first day of chemotherapy, then 1 dose every 12 hours for 4 months beginning at chemotherapy initiation.

BEHAVIORAL

Questionnaires

Completion of questionnaires at baseline, 1 time each week, at each chemo cycle, at end of treatment visit, and at 6 month follow up visit.

BEHAVIORAL

Sensory Test

Sensory test performed at baseline, 2 months, end of treatment visit, and at 6 month follow up visit.

Sponsors & Collaborators

  • American Cancer Society, Inc.

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Cathy Eng, MD, BA · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2019-02-14
Completion
2019-02-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01906008 on ClinicalTrials.gov