Prehabilitation program for patients with rectal cancer
The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial
This study is testing a prehabilitation program to see if it helps people with rectal cancer feel better before surgery compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06565052 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 18 and older with clinical stage II-III rectal cancer who are undergoing neoadjuvant treatment.
Not a fit: Patients with distant metastatic disease or significant comorbid conditions that contraindicate exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and recovery for patients with rectal cancer.
How similar studies have performed: Other studies have shown promising results with prehabilitation programs in surgical patients, suggesting potential benefits in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.