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

A Randomized Controlled Trial Testing the Effects of an Exercise Intervention on the Gut Microbiota in Colorectal Cancer Survivors: A Pilot and Feasibility Study

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.

Study Overview

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

Detailed Description

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive the supervised exercise intervention (in-person or virtual) three times weekly (TID) 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Greenlee; Phone Number: 206-667-4502; Email: hgreenlee@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Heather Greenlee; Phone Number: 206-667-4502; Email: hgreenlee@fredhutch.org
      • Principal Investigator: Heather Greenlee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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) 18.5-35 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 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo collection of blood samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Interview; Ancillary studies; Other: Exercise Intervention; Receive exercise intervention; Other: Exercise Intervention; Receive tele-coaching intervention
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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo collection of blood samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Interview; Ancillary studies; Other: Exercise Intervention; Receive exercise intervention; Other: Exercise Intervention; Receive tele-coaching intervention; Behavioral: Health Education; Receive health-related information

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of an 8 week supervised exercise intervention on fecal concentrations of butyrate	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.	At 8 weeks
Effects of an 8 week supervised exercise intervention on fecal concentrations of other short chain fatty acids	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.	At 8 weeks

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Heather Greenlee, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic; Specimen Handling
• Other Study ID Numbers: RG1123467; P30CA015704 (U.S. NIH Grant/Contract); NCI-2023-03747 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 20059 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No