Prehabilitation Program for Rectal Cancer

Recruiting at 1 trial location

Overseen By Jeffrey Meyerhardt, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Metastatic disease, Functional incapacity, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 33

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Jeffrey A. Meyerhardt

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for individuals with rectal cancer who are about to start neoadjuvant chemotherapy and/or radiation, followed by surgery. Specific eligibility details are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

I understand the study and agree to participate.

My condition is stage II-III rectal cancer.

English-Speaking

Exclusion Criteria

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

Comorbid conditions or cognitive/physical impairments that contraindicate exercise

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants in Group A undergo a prehabilitation program with virtual exercise sessions 3 days per week for 4 weeks, along with IMN supplementation and daily multivitamin.

4 weeks

Virtual exercise sessions 3 times per week

Neoadjuvant Therapy

Participants receive neoadjuvant chemotherapy and/or radiation before surgical resection.

Varies

Surgery

Participants undergo resection surgery per standard of care.

1 day

In-clinic visit for surgery

Postoperative Follow-up

Participants have an in-clinic 30-day postoperative visit to assess recovery and outcomes.

4 weeks

In-clinic visit at 30 days post-surgery

Treatment Details

Interventions

• Prehabilitation Program

Trial Overview The PROPEL Trial is testing the effectiveness of a prehabilitation program (Group A) compared to usual care (Group B) in improving outcomes for patients undergoing treatment for rectal cancer.

Participant Groups

Group I: Group A: Prehabilitation Program Experimental Treatment 1 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 * 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 II: Group B: Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+