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

NCT ID: NCT06565052

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2027-08-07

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 surgical resection.

The names of the groups in this research study are:

• Group A: Prehabilitation program
• Group B: Usual Care

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 (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.

Conditions

Rectal Cancer; Colorectal Cancer; Rectal Cancer Stage II; Rectal Cancer Stage III

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Prehabilitation Program

Intervention Type: BEHAVIORAL

A hybrid-based, prehabilitation regimen comprised of nutritional optimization (multivitamin and protein supplement shake) and virtual, aerobic and resistance exercise sessions with clinical exercise physiologists. Virtual exercise sessions will be performed via a HIPAA-compliant videoconferencing platform or by phone call. Mini-exercise cycle ergometer, dumbbells, and resistance bands will be provided and delivered to participant. Heart rate monitors and wi-fi enable tablet will be provided if needed.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prehabilitation Program

A hybrid-based, prehabilitation regimen comprised of nutritional optimization (multivitamin and protein supplement shake) and virtual, aerobic and resistance exercise sessions with clinical exercise physiologists. Virtual exercise sessions will be performed via a HIPAA-compliant videoconferencing platform or by phone call. Mini-exercise cycle ergometer, dumbbells, and resistance bands will be provided and delivered to participant. Heart rate monitors and wi-fi enable tablet will be provided if needed.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey A. Meyerhardt, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Meyerhardt, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jeffrey Meyerhardt, MD, MPH

Role: CONTACT

jeffrey_meyerhardt@dfci.harvard.edu

617-632-6855

Facility Contacts

Jeffrey Meyerhardt, MD, MPH

Role: primary

jeffrey_meyerhardt@dfci.harvard.edu

617-632-6855

Joel Goldberg, MD

Role: primary

JGOLDBERG1@PARTNERS.ORG

617-732-8460

Other Identifiers

24-384

Identifier Type: -

Identifier Source: org_study_id