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

August 14, 2025 updated by: Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
        • Principal Investigator:
          • Christina Dieli-Conwright, MPH, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient diagnosed with early-stage or metastatic colon or rectal cancer
  • Age at diagnosis 18-50 years; due to the specificity of the study question those outside the age bracket will not be included
  • No plans for major surgical intervention at the time of recruitment for a minimum of 12 weeks (i.e. study period; placement of port a cath is allowed)
  • No plans for radiation therapy at the time of recruitment for a minimum of 12 weeks
  • On or planning chemotherapy
  • Participate in less than or equal to 90 minutes of moderate-to-vigorous exercise per week
  • Medical clearance to perform exercise intervention and testing by their treating oncologist
  • No uncontrolled medical conditions that could be exacerbated with exercise
  • Ability to communicate and complete written forms in English
  • Ability to understand and the willingness to sign informed consent prior to any study-related procedures
  • Willing to travel to DFCI for necessary data collection

Exclusion Criteria:

  • Participate in more than 90 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention effects.
  • Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded.
  • Patients actively on a weigh loss diet and/or actively taking weight loss drugs. This could effect gut microbiome.
  • Patient with other active malignancies (excluding basal cell carcinoma).
  • Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Exercise Group

42 participants will be enrolled using a permuted blocked design with varying block size and will complete study procedures as follows:

  • Baseline in-office visit.
  • Completion of exercise sessions 3x weekly.
  • Post-intervention in-office visit.
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.
No Intervention: Group B: Waitlist Control Group

42 participants will be enrolled using a permuted blocked design with varying block size and will complete study procedures as follows:

  • Baseline in-office visit.
  • Participants will be asked to maintain baseline exercise behavior and/or usual, daily activities.
  • Post-intervention in-office visit. Participants will be offered to participate in the exercise program upon the completion of post-intervention assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut Microbiome Genomes
Time Frame: Baseline (Week 1) and Post-intervention (Week 13)
Gut Microbiome Sequencing will be conducted using the stool samples at Baseline and Post-Intervention. Gut Microbiome sequencing will be performed using DNA and RNA extraction, which will analyze microbial genomes.
Baseline (Week 1) and Post-intervention (Week 13)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Chemotherapy Toxicity
Time Frame: 12 weeks
To evaluate changes in chemotherapy toxicity following a exercise intervention in survivors of young-onset CRC undergoing chemotherapy.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Christina Dieli-Conwright, MPH, PhD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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