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

NCT06565052 | Recruiting

• 1 other identifier: 24-384
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Enrollment Rate

  The proportion of eligible individuals that are enrolled to the study. Feasibility of the intervention is defined as an enrollment rate of greater than 10% of approached, eligible participants.

  Baseline

Secondary Outcomes (33)

• Adherence Rate to the Prehabilitation Program

  At post-intervention (approximately Week 4)

• Completion Rate of Physical Function Testing (Group A)

  At post-intervention (approximately Week 4)

• Completion Rate of Physical Function Testing (Group B)

  At post-intervention (approximately Week 4)

• Completion Rate of Questionnaire Assessments

  At baseline and the postoperative visit (approximately Week 9)

• Participant Fall Rate (Group A)

  At post-intervention (approximately Week 4)

Study Arms (2)

Group A: Prehabilitation Program

EXPERIMENTAL

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.

Behavioral: Prehabilitation Program

Group B: Usual Care

NO INTERVENTION

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.

Interventions

Prehabilitation Program 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 A: Prehabilitation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases

Study Officials

• Jeffrey Meyerhardt, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Meyerhardt, MD, MPH

CONTACT

617-632-6855; jeffrey_meyerhardt@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators blinded to block size
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 21, 2024
• Study Start: December 15, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): August 7, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)