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Behavioral Intervention

Group A: 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
* Age greater than or equal to 18 years at time of enrollment.
* English-Speaking.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

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

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

Timeline

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

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

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,090 Previous Clinical Trials
343,682 Total Patients Enrolled
Jeffrey Meyerhardt, MD, MPHPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
2,862 Total Patients Enrolled
~27 spots leftby Aug 2026
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