Exercise program for young patients with colorectal cancer undergoing chemotherapy
Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial
This study is testing whether an exercise program can help young patients with colorectal cancer feel better during chemotherapy and improve their treatment results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06202183 on ClinicalTrials.gov |
What this trial studies
This research involves a randomized controlled trial to assess the effects of an exercise program on the gut microbiome, chemotherapy toxicity, and treatment outcomes in patients with early-stage or metastatic colorectal cancer. Participants will be randomly assigned to either an exercise group or a waitlist control group. The study will include screening for eligibility, blood tests, stool samples, and survey questionnaires over a period of up to 6 months. Approximately 84 individuals will participate, with funding provided by the American Cancer Society.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-50 diagnosed with early-stage or metastatic colorectal cancer who are starting chemotherapy and meet specific health criteria.
Not a fit: Patients who are outside the age range, have uncontrolled medical conditions, or are planning major surgical interventions or radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and reduce chemotherapy side effects for young patients with colorectal cancer.
How similar studies have performed: Other studies have shown promising results with exercise interventions in cancer treatment, suggesting potential benefits in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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. * Patients actively on a weigh loss diet and/or actively taking weight loss drugs. This could effect gut microbiome. * Patient with other active malignancies (excluding basal cell carcinoma). * Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
Where this trial is running
Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christina Dieli-Conwright, MPH, PhD — Dana-Farber Cancer Institute
- Study coordinator: Christina Dieli-Conwright, MPH, PhD
- Email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
- Phone: 617-582-8321
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.