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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Exercise Intervention — OTHER
    Receive exercise intervention
  • Exercise Intervention — OTHER
    Receive tele-coaching intervention
  • Health Education — BEHAVIORAL
    Receive health-related information
  • Interview — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary 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

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Heather Greenlee
206-667-4502
Heather Greenlee (PRINCIPAL_INVESTIGATOR)

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