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

Last updated: March 10, 2025
Sponsor: Dana-Farber Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rectal Cancer

Colorectal Cancer

Cancer

Treatment

Prehabilitation Program

Clinical Study ID

NCT06565052
24-384
  • Ages > 18
  • All Genders

Study 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 surgical resection.

The names of the groups in this research study are:

  • Group A: Prehabilitation program

  • Group B: Usual Care

Eligibility Criteria

Inclusion

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; andanticipated surgical resection to follow.

  • Able to understand the study procedures, agree to participate in the study program,and voluntarily provide informed consent.

Exclusion

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 primaryrectal cancer.

  • Currently enrolled in a separate clinical trial that would prohibit them fromperforming the tasks instructed in this trial.

  • Currently participating in more than 60 minutes of moderate-to-vigorous aerobicexercise per week over the past month. This study targets insufficiently activepersons to assess the effect of the described intervention, where additionalexercise done regularly will contaminate the intervention effects.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Prehabilitation Program
Phase:
Study Start date:
December 15, 2024
Estimated Completion Date:
August 07, 2027

Study 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 (chemotherapy and/or radiation) before surgical resection. Investigators hope that prehabilitation will result in improved outcomes after surgery.

Participants will be randomized into one of the study groups: Group A: prehabilitation program, or Group B: usual care. Randomization means that a participant is placed into a group by chance.

The research study procedures include screening for eligibility, in-clinic visits, physical exams, exercise training, blood tests, and questionnaires.

It is expected that about 40 participants will take part in this research study.

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

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