Clinical trial NCT05930496: Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stage II Colorectal Cancer AJCC v8
Stage III Colorectal Cancer AJCC v8
Colorectal Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-07-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Recruitment
timeFrame: Up to 8 weeks
measure: Adherence
timeFrame: Up to 8 weeks
measure: Retention
timeFrame: Up to 8 weeks
measure: Acceptability
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Effects of an 8 week supervised exercise intervention on fecal concentrations of butyrate
timeFrame: At 8 weeks
measure: Effects of an 8 week supervised exercise intervention on fecal concentrations of other short chain fatty acids
timeFrame: At 8 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Heather Greenlee
role: PRINCIPAL_INVESTIGATOR
References: