RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2024-07-22

Study Completion:2027-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06202183

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.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Christina Dieli-Conwright, MPH, PhD

CONTACT

617-582-8321

ChristinaM_Dieli-Conwright@dfci.harvard.edu

Principal Investigator

Christina Dieli-Conwright, MPH, PhD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Christina Dieli-Conwright, MPH, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-07-22

Study Completion Date2027-07-31

Study Record Updates

Study Start Date2024-07-22

Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Colorectal Cancer
Metastatic Colon Cancer
Metastatic Colorectal Cancer