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

Status: Recruiting

Location: See all (2) locations...

Intervention Type: Behavioral

Study Type: Interventional

Study Phase: Not Applicable

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

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

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• 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.

Locations

United States

Massachusetts

Brigham and Women's Hospital

RECRUITING

Boston

Dana-Farber Cancer Institute

RECRUITING

Boston

Contact Information

Primary

Jeffrey Meyerhardt, MD, MPH

jeffrey_meyerhardt@dfci.harvard.edu

617-632-6855

Time Frame

Start Date: 2024-12-15

Estimated Completion Date: 2027-08-07

Participants

Target number of participants: 40

Treatments

Experimental: Group A: Prehabilitation Program

Participants will be randomized in a 1:1 ratio using a permuted blocked design and stratified by neoadjuvant therapy received. Participants will complete the following:~* In-clinic baseline visit with assessments~* Virtual exercise sessions 3 days per week for 4 weeks.~* IMN supplementation and daily multivitamin starting at 4 weeks of the preoperative phase.~* Resection surgery per standard of care~* In-clinic 30 day postoperative visit.

No_intervention: Group B: Usual Care

Participants will be randomized in a 1:1 ratio using a permuted blocked design and stratified by neoadjuvant therapy received. Participants will complete the following:~* In-clinic baseline visit with assessments~* Resection surgery per standard of care~* In-clinic 30 day postoperative visit~* After completion of the study period, participants will be offered exercise equipment with an exercise instruction booklet.

Related Therapeutic Areas

Colorectal Cancer

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