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NCT05930496 | RECRUITING | Stage II Colorectal Cancer AJCC v8

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

Condition or disease

Stage II Colorectal Cancer Ajc V8

Stage III Coloresectal Cancer Ajcc v8

Colorectal Carcinoma

Intervention/treatment

Biospecimen Collection

Exercise Intervention

Exercise Intervention

Health Education

Interview

Questionnaire Administration

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
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
Actual Study Start Date : 2025-06-21
Estimated Primary Completion Date : 2025-10-31
Estimated Study Completion Date : 2025-10-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors

Location Details

NCT05930496

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Washington

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109