RECRUITING

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

Description

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

Study Details

Study overview

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

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

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

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Within the first four weeks of starting 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
  • * 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.
  • * Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dana-Farber Cancer Institute,

Christina Dieli-Conwright, MPH, PhD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

2027-07-31