This phase II 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.
Additional locations may be listed on ClinicalTrials.gov for NCT05930496.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Heather Greenlee
Phone: 206-667-4502
PRIMARY OBJECTIVE:
I. To assess feasibility as assessed by recruitment, adherence, retention, and acceptability.
SECONDARY OBJECTIVES:
I. To collect preliminary data to estimate the effects of 8 weeks of a supervised moderate-to-vigorous exercise (MVE) program on changes in fecal concentrations of butyrate and other short chain fatty acids in the exercise compared to control arm.
EXPLORATORY OBJECTIVES:
I. To investigate the effects of MVE on patient reported gastrointestinal (GI) symptoms.
II. Stool and blood will be stored for future analyses of gut microbial changes, including alpha- and beta-diversity, abundances of individual bacterial taxa and gene-families, and secondary bile acids; and blood-based biomarkers of colorectal cancer (CRC) progression (carcinoembryonic antigen, CEA, biomarkers of inflammation (c-reactive protein, CRP; albumin), and biomarkers of glucose metabolism (fasting glucose and insulin), respectively.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive the supervised exercise intervention 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 a session of supervised exercise followed by 7 weeks of tele-coaching sessions. Patients also undergo collection of blood samples on study.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorHeather Greenlee