RECRUITING

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

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Conditions

Stage II Colorectal Cancer AJCC v8Stage III Colorectal Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-04
Study Completion:2025-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05930496

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-70 years of age
  2. * Previous diagnosis of stage II-III CRC cancer
  3. * No known recurrent or metastatic disease
  4. * No comorbid or physical limitations that would limit participation at the discretion of the treating provider
  5. * 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)
  6. * Body mass index (BMI) 18.5-30 kg/m\^2
  7. * Able to understand and willing to sign written informed consent in English
  8. * Access to phone for study contacts
  9. * Be willing and able to attend the 24 sessions at the Fred Hutch Exercise Research Center Shared Resource
  10. * Access to smartphone
  11. * Willingness to participate in all study activities
  12. * Completion of all run-in activities
  13. * Participants must not be active smokers within the past 30 days. Active smoking is defined as any smoking, even a puff.
  14. * 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"
  15. * 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
  16. * Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status score of 0 or 1 for performance status
  17. * Physician approval for participation in an 8-week exercise program
  18. * Women must not be pregnant at time of enrollment
  1. * Use of oral or intravenous antibiotics, antifungals, or antiparasitics during the past 6 months
  2. * Presence of an ileostomy or colostomy because of known changes to the gut microbiome with ileostomies and colostomies
  3. * Current status of underweight (BMI \< 18.5 kg/m\^2) or obese (BMI 30.0 kg/m\^2)
  4. * 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
  5. * Active smokers within the past 30 days
  6. * Women who are pregnant or breastfeeding, or planning to become pregnant

Contacts and Locations

Study Contact

Heather Greenlee
CONTACT
206-667-4502
hgreenlee@fredhutch.org

Principal Investigator

Heather Greenlee
PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Fred Hutchinson Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-04
Study Completion Date2025-10-31

Study Record Updates

Study Start Date2024-12-04
Study Completion Date2025-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Stage II Colorectal Cancer AJCC v8
  • Stage III Colorectal Cancer AJCC v8