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

NCT ID: NCT05930496

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-08
• Study Completion Date: 2027-07-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm A (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.

Group Type: EXPERIMENTAL

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of blood samples

Exercise Intervention

Intervention Type: OTHER

Receive exercise intervention

Interview

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm B (waitlist control)

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.

Group Type: ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo collection of blood samples

Exercise Intervention

Intervention Type: OTHER

Receive tele-coaching intervention

Health Education

Intervention Type: BEHAVIORAL

Receive health-related information

Interview

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Biospecimen Collection

Undergo collection of blood samples

Intervention Type: PROCEDURE

Exercise Intervention

Receive exercise intervention

Intervention Type: OTHER

Exercise Intervention

Receive tele-coaching intervention

Intervention Type: OTHER

Health Education

Receive health-related information

Intervention Type: BEHAVIORAL

Interview

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Biological Sample Collection; Biospecimen Collected; Specimen Collection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Greenlee

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Heather Greenlee

Role: CONTACT

hgreenlee@fredhutch.org

206-667-4502

Facility Contacts

Heather Greenlee

Role: primary

hgreenlee@fredhutch.org

206-667-4502

Other Identifiers

NCI-2023-03747

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20059

Identifier Type: OTHER

Identifier Source: secondary_id

RG1123467

Identifier Type: -

Identifier Source: org_study_id