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Exercise and Gut Health for Colorectal Cancer Survivors

This study is looking at how a supervised exercise program affects the bacteria in the gut (gut microbiota) of people who have survived stage II or III colorectal cancer. We know that the gut bacteria can play a role in colorectal cancer, and exercise might improve outcomes for survivors. This trial wants to see if exercise changes the gut bacteria, and if those changes are linked to how the cancer progresses or how survivors feel. Participants will either join an exercise program with tele-coaching or receive health information, and blood samples will be collected. The main goals are to see how many people join, stick with the program, and stay in the study.

Study design
This is an interventional study with 30 participants, where you would be randomly assigned to one of two groups.
What's involved
You would participate in the study for 8 weeks, which includes supervised exercise sessions (in-person or virtual) or receiving health information, and blood sample collections.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for this study are measured up to 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05930496

Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors

Recruiting
NAAges 18–70InterventionalSupportive care
Fred Hutchinson Cancer Center
~30 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:Biospecimen CollectionExercise InterventionHealth EducationInterviewQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment
Measured over Up to 8 weeks
+3 more outcomes measured

Conditions

Stage II Colorectal Cancer AJCC v8
Stage III Colorectal Cancer AJCC v8
Colorectal Carcinoma

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Heather Greenlee · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Heather Greenlee
[email protected]
206-667-4502
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 and willing to sign written informed consent in English
Access to phone for study contacts
Access to a smart phone or tablet to connect to the Polar H10 Heart rate sensor during remote exercise sessions and attend virtual exercise sessions
Be willing and able to attend up to 24 sessions in-person at the Fred Hutch Exercise Research Center Shared Resource or virtually via phone, Zoom, or Microsoft Teams, based on participant preference
Access to internet (internet access may be provided on a case-by-case basis to participants where access to internet would otherwise be the only barrier to participation)
Willingness to participate in all study activities
Completion of all run-in activities
Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status score of 0 or 1 for performance status
Women must not be pregnant, breastfeeding, or planning to become pregnant

Exclusion

Use of oral or intravenous antibiotics, antifungals, or antiparasitics during the past 6 months
Presence of an ileostomy or colostomy because of known changes to the gut microbiome with ileostomies and colostomies
Current status of underweight (BMI \< 18.5 kg/m\^2) or class II/III obesity (BMI ≥ 35.0 kg/m\^2)
Presence of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis as these are known to baseline have differences in gut microbiome composition
Women who are pregnant, breastfeeding, or planning to become pregnant
Physician notification to not approach patient for the study

What this trial measures

  • RecruitmentUp to 8 weeks

    Recruitment (accrual rate) will be assessed to determine feasibility. Will be summarized using descriptive statistics.

  • AdherenceUp to 8 weeks

    Adherence will be measured by session attendance in the intervention arm to determine feasibility. Will be summarized using descriptive statistics.

  • RetentionUp to 8 weeks

    Retention will be measured by completion of all study assessments, including physical activity via accelerometry, 24 hour dietary recalls, and completion of the follow-up data collection at 8 weeks to determine feasibility. Will be summarized using descriptive statistics. Statistical differences in retention rates for each study assessment between study arms will be assessed by logistic regression models and acceptability by linear regression models, with models adjusted for stratification factors.

  • AcceptabilityUp to 8 weeks

    Acceptability will be measured on a Likert scale in each of a series of questions regarding various aspects of the trial during the exit interview to determine feasibility. Will be summarized using descriptive statistics.