Prehabilitation program for patients with rectal cancer

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 study aims to assess the feasibility of a prehabilitation program for patients diagnosed with rectal cancer who are undergoing neoadjuvant chemotherapy and/or radiation prior to surgical resection. Participants will be randomly assigned to either a prehabilitation program or usual care to evaluate the impact on their perioperative outcomes. The study involves screening for eligibility, in-clinic visits, physical exams, exercise training, blood tests, and questionnaires. Approximately 40 participants will be involved in this non-blinded, randomized control trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age greater than or equal to 18 years at time of enrollment.
* English-Speaking.
* Diagnosis of clinical stage II-III rectal cancer.
* Planned, ongoing or just completed neoadjuvant treatment, including either 1) chemoradiation, 2) total neoadjuvant therapy (TNT), or 3) chemotherapy only; and anticipated surgical resection to follow.
* Able to understand the study procedures, agree to participate in the study program, and voluntarily provide informed consent.

Exclusion Criteria:

* Distant metastatic disease known at the time of diagnosis.
* Functional incapacity (i.e., incapable of performing exercise testing).
* Comorbid conditions or cognitive/physical impairments that contraindicate exercise.
* Currently undergoing treatment for a secondary primary tumor, in addition to primary rectal cancer.
* Currently enrolled in a separate clinical trial that would prohibit them from performing the tasks instructed in this trial.
* Currently participating in more than 60 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 intervention, where additional exercise done regularly will contaminate the intervention effects.

Where it's running

• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Jeffrey Meyerhardt, MD, MPH — Dana-Farber Cancer Institute
• Study coordinator: Jeffrey Meyerhardt, MD, MPH
• Email: jeffrey_meyerhardt@dfci.harvard.edu
• Phone: 617-632-6855

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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.