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

NCT06202183 | Recruiting

• 1 other identifier: 23-341
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Colorectal Cancer; Metastatic Colon Cancer; Metastatic Colorectal Cancer

Keywords

Colorectal Cancer; Metastatic Colon Cancer; Metastatic Colorectal Cancer; Early Stage Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Gut Microbiome Genomes

  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 Outcomes (1)

• Change in Chemotherapy Toxicity

  12 weeks

Study Arms (2)

Group A: Exercise Group

EXPERIMENTAL

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

Group B: Waitlist Control Group

NO INTERVENTION

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.

Interventions

Exercise Program BEHAVIORAL

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.

Group A: Exercise Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christina Dieli-Conwright, MPH, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Dieli-Conwright, MPH, PhD

CONTACT

617-582-8321; ChristinaM_Dieli-Conwright@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: blinded to block size
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 11, 2024
• Study Start: July 22, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)