Exercise intervention for colorectal cancer survivors
A Randomized Controlled Trial Testing the Effects of an Exercise Intervention on the Gut Microbiota in Colorectal Cancer Survivors: A Pilot and Feasibility Study
This study tests whether an exercise program can change gut bacteria and help survivors of stage II-III colorectal cancer feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fred Hutchinson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05930496 on ClinicalTrials.gov |
What this trial studies
This trial evaluates how a moderate-to-vigorous exercise program affects the gut microbiota in survivors of stage II-III colorectal cancer. Participants are randomized into two groups: one receiving supervised exercise for eight weeks and the other receiving health-related information followed by exercise and tele-coaching. The study aims to understand the relationship between exercise, gut microbiota changes, and colorectal cancer progression. Blood samples will also be collected to assess biological markers related to the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 who have previously been diagnosed with stage II-III colorectal cancer and are at least 60 days post-treatment.
Not a fit: Patients with current, recurrent, or metastatic colorectal cancer or those with significant comorbidities that limit exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the health outcomes and quality of life for colorectal cancer survivors through targeted exercise interventions.
How similar studies have performed: Previous studies have indicated that exercise can positively influence cancer prognosis, suggesting potential success for this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Heather Greenlee — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Heather Greenlee
- Email: hgreenlee@fredhutch.org
- Phone: 206-667-4502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.