Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial
Recruiting · NCT06202183 · Interventional (participants receive a specific treatment) · Lead sponsor: Dana-Farber Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
Exercise Program
What this trial is about
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
Who can take part
Age range
18 Years to 50 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Dana Farber Cancer Institute - Boston, Massachusetts, United States