NCT06202183Recruiting
Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
This research study is a randomized controlled trial that will observe changes in microbiome activity, changes in chemotherapy toxicity, and any changes in treatment outcomes between two groups of participants undergoing chemotherapy with either early-stage or metastatic colorectal cancer. The names of the study groups involved in this study are: * Exercise * Waitlist Control
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 2 Jan 2024
- Start date
- 22 Jul 2024
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Colorectal cancer
- NCT number
- NCT06202183
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 22 Jul 2024 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients actively on a weigh loss diet and/or actively taking weight loss drugs. This could effect gut microbiome.
Other illness
- Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded.
- Patient with other active malignancies (excluding basal cell carcinoma).
Other
- Participate in more than 90 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention effects.
- Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
Who the study is looking for
- Patient diagnosed with early-stage or metastatic colon or rectal cancer
- Age at diagnosis 18-50 years; due to the specificity of the study question those outside the age bracket will not be included
- No plans for major surgical intervention at the time of recruitment for a minimum of 12 weeks (i.e. study period; placement of port a cath is allowed)
- No plans for radiation therapy at the time of recruitment for a minimum of 12 weeks
- On or planning chemotherapy
- Participate in less than or equal to 90 minutes of moderate-to-vigorous exercise per week
- Medical clearance to perform exercise intervention and testing by their treating oncologist
- No uncontrolled medical conditions that could be exacerbated with exercise
- Ability to communicate and complete written forms in English
- Ability to understand and the willingness to sign informed consent prior to any study-related procedures
- Willing to travel to DFCI for necessary data collection
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.