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Behavioral Intervention

Prehabilitation Program for Rectal Cancer

N/A

Waitlist Available

Led By Jeffrey Meyerhardt, MD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of clinical stage II-III rectal cancer

Age greater than or equal to 18 years at time of enrollment

Must not have

Distant metastatic disease known at the time of diagnosis

Functional incapacity (i.e., incapable of performing exercise testing)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a pre-surgery exercise and education program can help rectal cancer patients receiving chemotherapy and/or radiation before surgery. One group will have the prehabilitation program, while the

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a prehabilitation program rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is stage II-III rectal cancer.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer was already spread to distant parts of my body when diagnosed.

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I am unable to perform any exercise tests due to my condition.

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I am being treated for another type of cancer besides rectal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Enrollment Rate

Secondary study objectives

Adherence Rate to the Prehabilitation Program

Change in Body Mass Index from Baseline to Post-Intervention

Change in Cardiorespiratory Fitness from Baseline to Post-Intervention

+30 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group A: Prehabilitation ProgramExperimental Treatment1 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 CareActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prehabilitation Program

2018

Completed Early Phase 1

~100

0 / 5Eligibility criteria met