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

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

Inclusion 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

- 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

Exclusion Criteria:

- 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.