NCT06202183

Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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 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

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 between two groups of participants undergoing chemotherapy with either early-stage or metastatic colorectal cancer. Participants will be randomly assigned to one of two groups: Group A: Exercise group (EXE) vs. Group B: Waitlist control group (WC). Randomization means that a participant will be placed into one of the study groups by chance. The research study procedures include screening for eligibility, blood tests, stool samples, and survey questionnaires. Participation in this research study will last up to 6 months. It is expected that about 84 people will take part in this research study. The American Cancer Society is providing funding for this research study.

Conditions

• Colorectal Cancer
• Metastatic Colon Cancer
• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Program	A 12 week, home-based, virtually supervised, aerobic and resistance exercise training program comprised of 36 sessions. Participants will be provided with a home stationary bike, resistance bands, and Fitbit. Virtually supervised sessions will be accessible via Zoom platform. For participants who do not have a device, a Wi-Fi-enabled tablet will also be provided.

Timeline

• Start date: 2024-07-22
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2024-01-11
• Last updated: 2025-08-15

Locations

1 site across 1 country: United States