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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.

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.

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.

Exercise Program

Christina Dieli-Conwright, MPH, PhD

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

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.

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

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.

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.

To evaluate changes in chemotherapy toxicity following a exercise intervention in survivors of young-onset CRC undergoing chemotherapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial	NCT06202183	Colorectal Canc... Metastatic Colo... Metastatic Colo...	Exercise Progra...	18 Years - 50 Years	Dana-Farber Cancer Institute
Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial	NCT06202183	Colorectal Canc... Metastatic Colo... Metastatic Colo...	Exercise Progra...	18 Years - 50 Years	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for early stage colorectal cancer