A Randomized Controlled Trial Testing the Effects of an Exercise Intervention on the Gut Microbiota in Colorectal Cancer Survivors: A Pilot and Feasibility Study
Fred Hutchinson Cancer Center
Summary
This trial evaluates the effects a moderate-to-vigorous exercise intervention has on the bacterial make-up of the gastrointestinal tract (gut microbiota) in survivors of stage II-III colorectal cancer (CRC). Data shows that the gut microbiota composition and function may be drivers of CRC. High levels of exercise are associated with improved CRC prognosis and survival. While data suggests that exercise has the potential to influence gut microbiota composition and function, it is not known whether these effects contribute to improved CRC prognosis. This clinical trial evaluates the effects an exercise intervention has on gut microbiota and how these effects relate to CRC progression and patient-reported outcomes.
Description
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.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- OtherExercise Intervention
Receive exercise intervention
- OtherExercise Intervention
Receive tele-coaching intervention
- BehavioralHealth Education
Receive health-related information
- OtherInterview
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington