Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Exercise Intervention, Exercise Intervention, Health Education.
- Who it may be relevant to
- Registry conditions: Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Colorectal Carcinoma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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 (in-person or virtual) three times weekly (TID) 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 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.
Interventions
- Procedure Biospecimen Collection
Undergo collection of blood samples - Other Exercise Intervention
Receive exercise intervention - Other Exercise Intervention
Receive tele-coaching intervention - Behavioral Health Education
Receive health-related information - Other Interview
Ancillary studies - Other Questionnaire Administration
Ancillary studies
Primary outcome measures
- Recruitment [Time frame: Up to 8 weeks]
- Adherence [Time frame: Up to 8 weeks]
- Retention [Time frame: Up to 8 weeks]
- Acceptability [Time frame: Up to 8 weeks]
Secondary outcome measures (2)
- Effects of an 8 week supervised exercise intervention on fecal concentrations of butyrate [Time frame: At 8 weeks]
- Effects of an 8 week supervised exercise intervention on fecal concentrations of other short chain fatty acids [Time frame: At 8 weeks]
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) 18.5-35 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
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Fred Hutch/University of Washington Cancer Consortium — Seattle
Identifiers
NCT: NCT05930496 · RG1123467 · NCI-2023-03747 · P30CA015704 · 20059