Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
NCT06202183

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

157 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 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

Official Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with early-stage or metastatic colon or rectal cancer
  • Age between 18 and 50 years at diagnosis
  • No major surgery planned for at least 12 weeks during the study (port a cath placement allowed)
  • No radiation therapy planned for at least 12 weeks during the study
  • Currently on or planning to start chemotherapy
  • Engages in 90 minutes or less of moderate-to-vigorous exercise per week
  • Medical clearance from oncologist to perform exercise and testing
  • No uncontrolled medical conditions that could worsen with exercise
  • Able to communicate and complete written forms in English
  • Willing to sign informed consent before study procedures
  • Willing to travel to Dana-Farber Cancer Institute for data collection
Not Eligible

You will not qualify if you...

  • Engages in more than 90 minutes of moderate-to-vigorous aerobic exercise per week in the past month
  • Has unstable medical conditions that prevent safe participation in moderate-to-vigorous exercise
  • Currently on a weight loss diet or taking weight loss drugs
  • Has other active cancers (except basal cell carcinoma)
  • Unable to comply with safety monitoring requirements of the study as judged by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

C

Christina Dieli-Conwright, MPH, PhD

CONTACT

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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