Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial
NCT06202183 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2025-08-15
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
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
American Cancer Society, Inc.
collaborator OTHER - lead OTHER
Principal Investigators
-
Christina Dieli-Conwright, MPH, PhD · Dana-Farber Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-22
- Primary Completion
- 2026-07-31
- Completion
- 2027-07-31
Countries
- United States
Study Locations
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