Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial

Launched by DANA-FARBER CANCER INSTITUTE · Jan 2, 2024

Keywords

ClinConnect Summary

The COURAGE Trial is a research study looking at how exercise might affect gut health and treatment outcomes in younger patients (ages 18-50) with colorectal cancer who are undergoing chemotherapy. The study will have two groups: one group will engage in a structured exercise program, while the other will be on a waitlist and will not exercise as part of the study. Researchers want to see if the exercise group experiences less toxicity from chemotherapy and if their overall treatment results improve compared to those who do not exercise.

To be eligible for the trial, participants need to be diagnosed with either early-stage or metastatic colon or rectal cancer, and they should be starting chemotherapy soon. They should also be exercising less than 90 minutes a week before joining the study. Participants will receive medical clearance to ensure they can safely take part in the exercise program. This study is currently recruiting, and participants will need to travel to the Dana-Farber Cancer Institute for some of the study activities. Overall, the COURAGE Trial aims to understand the potential benefits of exercise during cancer treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient diagnosed with early-stage or metastatic colon or rectal cancer
• • Age at diagnosis 18-50 years; due to the specificity of the study question those outside the age bracket will not be included
• • No plans for major surgical intervention at the time of recruitment for a minimum of 12 weeks (i.e. study period; placement of port a cath is allowed)
• • No plans for radiation therapy at the time of recruitment for a minimum of 12 weeks
• • On or planning chemotherapy
• • Participate in less than or equal to 90 minutes of moderate-to-vigorous exercise per week
• • Medical clearance to perform exercise intervention and testing by their treating oncologist
• • No uncontrolled medical conditions that could be exacerbated with exercise
• • Ability to communicate and complete written forms in English
• • Ability to understand and the willingness to sign informed consent prior to any study-related procedures
• • Willing to travel to DFCI for necessary data collection
• Exclusion Criteria:
• • Participate in more than 90 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention effects.
• • Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded.
• • Patients actively on a weigh loss diet and/or actively taking weight loss drugs. This could effect gut microbiome.
• • Patient with other active malignancies (excluding basal cell carcinoma).
• • Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.