Recruiting

PReOPerative Optimization

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06565052

Conditions

Rectal Cancer

Colorectal Cancer

Rectal Cancer Stage II

Rectal Cancer Stage III

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prehabilitation Program

Study Details

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

Study ID

NCT06565052

Start date

Dec 15, 2024

Status verified date

Nov, 2025

Completion date

Aug 7, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Enrollment Rate [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Jeffrey Meyerhardt, MD, MPH

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

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jeffrey Meyerhardt, MD, MPH

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

Principal Investigator:

Jeffrey Meyerhardt, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Joel Goldberg, MD

617-732-8460JGOLDBERG1@PARTNERS.ORG

Principal Investigator:

Joel Goldberg, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • Rectal Cancer
  • Colorectal Cancer
  • Rectal Cancer Stage II
  • Rectal Cancer Stage III

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2025-11-24.