Colorectal Carcinoma, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8
Conditions
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 (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
PROCEDUREBiospecimen Collection
Undergo collection of blood samples
OTHERExercise Intervention
Receive exercise intervention
BEHAVIORALHealth Education
Receive health-related information
OTHERInterview
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | Up to 8 weeks | Recruitment (accrual rate) will be assessed to determine feasibility. Will be summarized using descriptive statistics. |
| Adherence | Up to 8 weeks | Adherence will be measured by session attendance in the intervention arm to determine feasibility. Will be summarized using descriptive statistics. |
| Retention | Up to 8 weeks | 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. |
| Acceptability | Up to 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of an 8 week supervised exercise intervention on fecal concentrations of butyrate | At 8 weeks | Will be summarized using descriptive statistics, and statistical differences between study arms will be assessed via linear regression models with adjustment for baseline outcome values and stratification factors. |
| Effects of an 8 week supervised exercise intervention on fecal concentrations of other short chain fatty acids | At 8 weeks | Will be summarized using descriptive statistics, and statistical differences between study arms will be assessed via linear regression models with adjustment for baseline outcome values and stratification factors. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHeather Greenlee
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed