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

Not Applicable

Recruiting

• Conditions: Stage II Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Colorectal Carcinoma
• Interventions: Procedure: Biospecimen Collection; Other: Exercise Intervention; Behavioral: Health Education; Other: Interview; Other: Questionnaire Administration

• Registration Number: NCT05930496
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-07-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Study Start: 2025-05-18
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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) 18.5-30 kg/m^2

• Able to understand and willing to sign written informed consent in English

• Access to phone for study contacts

• Be willing and able to attend the 24 sessions at the Fred Hutch Exercise Research Center Shared Resource

• Access to internet

• Willingness to participate in all study activities

• Completion of all run-in activities

• Participants must not be active smokers within the past 30 days. Active smoking is defined as any smoking (of cigarettes or tobacco products), even a puff

  • Participants who smoke are much less likely to engage in healthy lifestyle behaviors, and it is probably more important for participants to stop smoking than it is to change their exercise patterns. If identified as a smoker, the individual will be referred to the local resources, Washington State Quitline (1-800-QUIT-NOW), ICanQuit.org, Quit2Heal.org, the national resource, Centers for Disease Control and Prevention (CDC) "Quit Now" phone line which supports smoking cessation, or the National Institutes of Health (NIH) quit support website "SmokeFree.gov"

• At time of consent, participants must engage =< 60 minutes per week of moderate to vigorous physical activity, as assessed by brief questionnaires at screening and then objectively assessed using accelerometers at baseline

• Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status score of 0 or 1 for performance status

• Physician approval for participation in an 8-week exercise program

• Women must not be pregnant, breastfeeding, or planning to become pregnant

Exclusion Criteria

• 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 obese (BMI >= 30.0 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
• Active smokers within the past 30 days
• Women who are pregnant, breastfeeding, or planning to become pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B (waitlist control)	Interview	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 at baseline and week 8.
Arm A (exercise intervention)	Exercise Intervention	Patients receive the supervised exercise intervention over 8 weeks on study. Patients also undergo collection of blood samples at baseline and week 8.
Arm A (exercise intervention)	Questionnaire Administration	Patients receive the supervised exercise intervention over 8 weeks on study. Patients also undergo collection of blood samples at baseline and week 8.
Arm A (exercise intervention)	Interview	Patients receive the supervised exercise intervention over 8 weeks on study. Patients also undergo collection of blood samples at baseline and week 8.
Arm B (waitlist control)	Biospecimen Collection	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 at baseline and week 8.
Arm A (exercise intervention)	Biospecimen Collection	Patients receive the supervised exercise intervention over 8 weeks on study. Patients also undergo collection of blood samples at baseline and week 8.
Arm B (waitlist control)	Health Education	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 at baseline and week 8.
Arm B (waitlist control)	Exercise Intervention	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 at baseline and week 8.
Arm B (waitlist control)	Questionnaire Administration	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 at baseline and week 8.

Primary Outcome Measures

Name	Time	Method
Adherence	Up to 8 weeks	Adherence will be measured by session attendance in the intervention arm to determine feasibility. Will be summarized using descriptive statistics.
Retention	Up 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.
Acceptability	Up 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.
Recruitment	Up to 8 weeks	Recruitment (accrual rate) will be assessed to determine feasibility. Will be summarized using descriptive statistics.

Secondary Outcome Measures

Name	Time	Method
Effects of an 8 week supervised exercise intervention on fecal concentrations of butyrate	At 8 weeks	Will be summarized using descriptive statistics, and statistical differences between study arms will be assessed via linear regression models with adjustment for baseline outcome values and stratification factors.
Effects of an 8 week supervised exercise intervention on fecal concentrations of other short chain fatty acids	At 8 weeks	Will be summarized using descriptive statistics, and statistical differences between study arms will be assessed via linear regression models with adjustment for baseline outcome values and stratification factors.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States