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

Launched by FRED HUTCHINSON CANCER CENTER · Jun 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a structured exercise program can affect the bacteria in the gut of survivors of stage II and III colorectal cancer. Researchers believe that the types and amounts of bacteria in our gut might play a role in cancer outcomes. While previous studies suggest that being active can help improve survival rates for colorectal cancer, it’s not yet clear if exercise changes gut bacteria in a way that benefits cancer recovery. This trial aims to find out if exercising can positively influence gut health and, in turn, affect cancer progression and patients' overall well-being.

To participate in this study, individuals need to be between 18 and 70 years old, have a prior diagnosis of stage II or III colorectal cancer, and be at least 60 days out from their last cancer treatment. They should also have a body mass index (BMI) between 18.5 and 30, and be currently getting less than 60 minutes of moderate to vigorous exercise per week. Participants will attend 24 exercise sessions at the Fred Hutch Exercise Research Center, where they will engage in an 8-week exercise program designed to be safe and beneficial. It’s important for potential participants to know that they will need to be approved by their doctor to join the study and must not be active smokers or have certain health conditions that could interfere with the trial.

Gender

ALL

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