Exercise program for young patients with colorectal cancer undergoing chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research involves a randomized controlled trial to assess the effects of an exercise program on the gut microbiome, chemotherapy toxicity, and treatment outcomes in patients with early-stage or metastatic colorectal cancer. Participants will be randomly assigned to either an exercise group or a waitlist control group. The study will include screening for eligibility, blood tests, stool samples, and survey questionnaires over a period of up to 6 months. Approximately 84 individuals will participate, with funding provided by the American Cancer Society.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Christina Dieli-Conwright, MPH, PhD — Dana-Farber Cancer Institute
• Study coordinator: Christina Dieli-Conwright, MPH, PhD
• Email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
• Phone: 617-582-8321

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.