This research study is a randomized controlled trial that will observe changes in microbiome activity, changes in chemotherapy toxicity, and any changes in treatment outcomes between two groups of participants undergoing chemotherapy with either early-stage or metastatic colorectal cancer.
The names of the study groups involved in this study are:
* Exercise * Waitlist Control
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
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).
Parallel
Exercise Program
BehavioralA 12 week, home-based, virtually supervised, aerobic and resistance exercise training program comprised of 36 sessions. Participants will be provided with a home stationary bike, resistance bands, and Fitbit. Virtually supervised sessions will be accessible via Zoom platform. For participants who do not have a device, a Wi-Fi-enabled tablet will also be provided.
Gut Microbiome Genomes
Gut Microbiome Sequencing will be conducted using the stool samples at Baseline and Post-Intervention. Gut Microbiome sequencing will be performed using DNA and RNA extraction, which will analyze microbial genomes.
Change in Chemotherapy Toxicity
To evaluate changes in chemotherapy toxicity following a exercise intervention in survivors of young-onset CRC undergoing chemotherapy.
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Dana-Farber Cancer Institute
Lead sponsor
American Cancer Society, Inc.
Collaborator
