RecruitingNot ApplicableNCT06202183

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


Sponsor

Dana-Farber Cancer Institute

Enrollment

84 participants

Start Date

Jul 22, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial (COURAGE) studies whether a structured exercise program can change the gut bacteria (microbiome) and immune system in young adults (under 50) with colorectal cancer who are receiving chemotherapy. **You may be eligible if...** - You were diagnosed with colon or rectal cancer between ages 18 and 50 - You are currently on chemotherapy or about to start - You currently exercise less than 90 minutes per week at moderate or vigorous intensity - You have medical clearance from your oncologist to exercise - You have no major surgery or radiation therapy planned for the next 12 weeks - You are able to communicate in English and travel to the Dana-Farber Cancer Institute (DFCI) for visits **You may NOT be eligible if...** - You currently exercise more than 90 minutes per week - You have unstable health conditions that make exercise unsafe - You are actively on a weight-loss diet or taking weight-loss drugs - You have another active cancer (other than basal cell skin cancer) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALExercise 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.


Locations(1)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

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NCT06202183


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