Actively Recruiting
Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors
Led by Fred Hutchinson Cancer Center · Updated on 2026-04-20
30
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Previous diagnosis of stage II or III colorectal cancer
- No current, recurrent, or metastatic cancer
- No physical or medical conditions limiting exercise participation as judged by provider
- At least 60 days and up to 3 years since last cancer treatment (excluding elective surgeries like ileostomy reversal)
- Body mass index between 18.5 and 35 kg/m^2
- Able to understand and sign informed consent in English
- Access to phone for study communication
- Access to smartphone or tablet to use Polar H10 Heart rate sensor for virtual sessions
- Willing and able to attend up to 24 exercise sessions in person or virtually
- Access to internet (may be provided if needed)
- Willing to participate in all study activities
- Completion of all initial run-in activities
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Women must not be pregnant, breastfeeding, or planning pregnancy
You will not qualify if you...
- Use of oral or intravenous antibiotics, antifungals, or antiparasitics in the past 6 months
- Presence of ileostomy or colostomy
- Underweight (BMI less than 18.5 kg/m^2) or class II/III obesity (BMI 35 or higher)
- Diagnosis of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis
- Women who are pregnant, breastfeeding, or planning pregnancy
- Physician has advised not to approach the patient for the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
H
Heather Greenlee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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