Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive the supervised exercise intervention (in-person or virtual) three times weekly (TID) over 8 weeks on study. Patients also undergo collection of blood samples on study.

ARM B: Patients receive health-related information for 8 weeks on study. Patients are then offered an in-person session of supervised exercise followed by weekly virtual tele-coaching sessions for 7 weeks. Patients also undergo collection of blood samples on study.

Inclusion criteria

• 18-70 years of age
• Previous diagnosis of stage II-III CRC cancer
• No known current, recurrent, or metastatic disease
• No comorbid or physical limitations that would limit participation at the discretion of the treating provider
• At least 60 days to 3 years from last cancer-directed treatment (including surgery, chemotherapy, and radiation. Elective surgery, including ileostomy reversal, is not counted in this timing but patients must be able to eat a normal diet, without post-operative dietary limitations)
• Body mass index (BMI) 18.5-35 kg/m^2
• Able to understand and willing to sign written informed consent in English
• Access to phone for study contacts
• Access to a smart phone or tablet to connect to the Polar H10 Heart rate sensor during remote exercise sessions and attend virtual exercise sessions
• Be willing and able to attend up to 24 sessions in-person at the Fred Hutch Exercise Research Center Shared Resource or virtually via phone, Zoom, or Microsoft Teams, based on participant preference
• Access to internet (internet access may be provided on a case-by-case basis to participants where access to internet would otherwise be the only barrier to participation)
• Willingness to participate in all study activities
• Completion of all run-in activities
• Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status score of 0 or 1 for performance status
• Women must not be pregnant, breastfeeding, or planning to become pregnant

Exclusion criteria

• Use of oral or intravenous antibiotics, antifungals, or antiparasitics during the past 6 months
• Presence of an ileostomy or colostomy because of known changes to the gut microbiome with ileostomies and colostomies
• Current status of underweight (BMI < 18.5 kg/m^2) or class II/III obesity (BMI ≥ 35.0 kg/m^2)
• Presence of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis as these are known to baseline have differences in gut microbiome composition
• Women who are pregnant, breastfeeding, or planning to become pregnant
• Physician notification to not approach patient for the study