A Home-Based Exercise Intervention for Modifying the Gut Microbiome among Patients Receiving Chemotherapy for Early-stage or Metastatic Colorectal Cancer, COURAGE Trial

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 catheter [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 structured moderate-to-vigorous aerobic and/or resistance 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
• Does not smoke or vape (no smoking/vaping during previous 12 months). Those who infrequently smoke or vape in social settings will be included
• The effects of exercise on the developing fetus are unknown. For this reason, people of child-bearing potential must agree to undergo a pregnancy test and to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a participant become pregnant or suspect that they are pregnant while participating on the trial, they should inform her treating physician immediately
• Willing to travel to Dana-Farber Cancer Institute (DFCI) for necessary data collection

Exclusion Criteria

• Participate in more than 90 minutes of structured moderate-to-vigorous aerobic and/or resistance 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 weight loss diet and/or actively taking weight loss drugs. This could affect gut microbiome
• Patients 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