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Trial Title:
Evaluating the Effects of an Exercise Intervention on the Gut Microbiota in Stage II-III Colorectal Cancer Survivors
NCT ID:
NCT05930496
Condition:
Stage II Colorectal Cancer AJCC v8
Stage III Colorectal Cancer AJCC v8
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Arm A (exercise intervention)
Arm group label:
Arm B (waitlist control)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
Receive exercise intervention
Arm group label:
Arm A (exercise intervention)
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
Receive tele-coaching intervention
Arm group label:
Arm B (waitlist control)
Intervention type:
Behavioral
Intervention name:
Health Education
Description:
Receive health-related information
Arm group label:
Arm B (waitlist control)
Intervention type:
Other
Intervention name:
Interview
Description:
Ancillary studies
Arm group label:
Arm A (exercise intervention)
Arm group label:
Arm B (waitlist control)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm A (exercise intervention)
Arm group label:
Arm B (waitlist control)
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 at baseline and week 8.
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 at baseline and week 8.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18-70 years of age
- Previous diagnosis of stage II-III CRC cancer
- No known 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 smartphone
- 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, 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 at time of enrollment
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 or breastfeeding, or planning to become pregnant
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Greenlee
Phone:
206-667-4502
Email:
hgreenlee@fredhutch.org
Investigator:
Last name:
Heather Greenlee
Email:
Principal Investigator
Start date:
December 4, 2024
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Fred Hutchinson Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Fred Hutchinson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05930496
