Status:
RECRUITING
Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
American Cancer Society, Inc.
Conditions:
Colorectal Cancer
Metastatic Colon Cancer
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
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 par...
Detailed Description
This research study is a single-center, two-armed, randomized controlled trial that will observe changes in microbiome activity, changes in chemotherapy toxicity, and any changes in treatment outcomes...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06202183
Start Date
July 22 2024
End Date
July 31 2027
Last Update
August 15 2025
Active Locations (1)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215