Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors
Part of paid clinical trials in Seattle, Washington.
- Sponsor
- Fred Hutchinson Cancer Center
- Study ID
- NCT05930496
- Status
- Recruiting
Conditions
- Colorectal Carcinoma
- Stage II Colorectal Cancer AJCC v8
- Stage III Colorectal Cancer AJCC v8
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo collection of blood samples
- Exercise Intervention — OTHERReceive exercise intervention
- Exercise Intervention — OTHERReceive tele-coaching intervention
- Health Education — BEHAVIORALReceive health-related information
- Interview — OTHERAncillary studies
- Questionnaire Administration — OTHERAncillary studies
Study Details
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.
Key Dates
- Start date
- Jul 8, 2025
- Status verified
- Apr 2026
- Primary completion
- Jan 1, 2027
- Completion
- Jul 1, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Arm A (exercise intervention)Patients receive the supervised exercise intervention (in-person or virtual) TID over 8 weeks on study. Patients also undergo collection of blood samples on study.
- Active Comparator: Arm B (waitlist control)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.
Primary Outcome Measure
Recruitment [ Time Frame: Up to 8 weeks ]
Central Contacts
- Heather Greenlee206-667-4502
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | Heather Greenlee (PRINCIPAL_INVESTIGATOR) |
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