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

NCT05930496 | Recruiting

• 4 other identifiers: RG1123467NCI-2023-03747P30CA01570420059
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Effects of an 8 week supervised exercise intervention on fecal concentrations of butyrate

  At 8 weeks

• Effects of an 8 week supervised exercise intervention on fecal concentrations of other short chain fatty acids

  At 8 weeks

Study Arms (2)

Arm A (exercise intervention)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Other: Exercise Intervention; Other: Interview; Other: Questionnaire Administration

Arm B (waitlist control)

ACTIVE COMPARATOR

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.

Procedure: Biospecimen Collection; Other: Exercise Intervention; Behavioral: Health Education; Other: Interview; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm A (exercise intervention); Arm B (waitlist control)

Exercise Intervention OTHER

Receive exercise intervention

Arm A (exercise intervention)

Health Education BEHAVIORAL

Receive health-related information

Arm B (waitlist control)

Interview OTHER

Ancillary studies

Arm A (exercise intervention); Arm B (waitlist control)

Questionnaire Administration OTHER

Ancillary studies

Arm A (exercise intervention); Arm B (waitlist control)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Specimen Handling; Interviews as Topic

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Heather Greenlee

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Greenlee

CONTACT

206-667-4502; hgreenlee@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: July 8, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)