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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Christina Dieli-Conwright, MPH, PhD
ChristinaM_Dieli-Conwright@dfci.harvard.edu
617-582-8321
Time Frame
Start Date: 2024-07-22
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 84
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Dana-Farber Cancer Institute
Collaborators: American Cancer Society, Inc.

This content was sourced from clinicaltrials.gov

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