Actively Recruiting
Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial
Led by Dana-Farber Cancer Institute · Updated on 2025-08-15
84
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
A
American Cancer Society, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research trial is designed to study adults aged 18 to 50 years with early-stage or metastatic colorectal or colon cancer who are undergoing chemotherapy. The trial aims to observe how a structured exercise program might affect the gut microbiome activity, chemotherapy side effects, and treatment outcomes. The study is randomized and compares participants who follow an exercise program with those in a waitlist control group. It is funded by the American Cancer Society and led by the Dana-Farber Cancer Institute. Participants will be randomly assigned to one of two groups: the Exercise Group or the Waitlist Control Group. The Exercise Group will complete a 12-week home-based aerobic and resistance training program with 36 sessions, supported virtually via Zoom and provided with equipment including a stationary bike, resistance bands, and a Fitbit. Those in the Waitlist Control Group will maintain their usual physical activity during the study and may join the exercise program after completing the study. Both groups will attend baseline and post-intervention visits at the study center. During the study, participants will undergo screening, blood tests, stool sample collections, and complete questionnaires. Researchers will measure changes in gut microbiome genomes at the start and after 13 weeks, as well as changes in chemotherapy toxicity over 12 weeks. The total participation time is up to six months. Safety monitoring, data collection, and adherence to the exercise program will be part of the study procedures to evaluate the effects of exercise on treatment and microbiome activity.
CONDITIONS
Brief Title
Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with early-stage or metastatic colon or rectal cancer
- Aged 18 to 50 years at diagnosis
- No planned major surgery for at least 12 weeks (port placement allowed)
- No planned radiation therapy for at least 12 weeks
- Currently on or planning chemotherapy
- Performs 90 minutes or less of moderate-to-vigorous exercise per week
- Medical approval from oncologist to perform exercise
- No uncontrolled medical conditions that could worsen with exercise
- Able to communicate and complete forms in English
- Willing to sign informed consent
- Willing to travel to study site for data collection
You will not qualify if you...
- Performs more than 90 minutes of moderate-to-vigorous aerobic exercise per week
- Has unstable medical conditions preventing moderate-to-vigorous exercise
- Actively on a weight loss diet or taking weight loss drugs
- Has other active cancers except basal cell carcinoma
- May not comply with safety monitoring requirements as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants in the exercise group complete a 12-week, home-based, virtually supervised aerobic and resistance exercise program with 36 sessions, while participants in the waitlist control group maintain usual activities.
Baseline in-office visit and post-intervention in-office visit
Trial Site Locations
Total: 1 location
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
C
Christina Dieli-Conwright, MPH, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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