The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: the PROPEL Trial

Description

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 surgical resection. The names of the groups in this research study are: * Group A: Prehabilitation program * Group B: Usual Care

Conditions

Rectal Cancer, Colorectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III

Study Overview

Study Details

Study overview

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 surgical resection. The names of the groups in this research study are: * Group A: Prehabilitation program * Group B: Usual Care

The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: the PROPEL Trial

The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: the PROPEL Trial

Condition
Rectal Cancer
Intervention / Treatment

-

Contacts and Locations

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02115

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dana-Farber Cancer Institute,

Jeffrey Meyerhardt, MD, MPH, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

2027-08-07