Status:
RECRUITING
The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Rectal Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy and/or radiation, followed by s...
Detailed Description
This is a non-blinded, randomized control trial to determine the feasibility of a hybrid-model, prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant therapy (ch...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 7 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06565052
Start Date
December 15 2024
End Date
August 7 2027
Last Update
November 24 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215