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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a prehabilitation program might assist people with rectal cancer undergoing chemotherapy or radiation before surgery. The program includes virtual exercise sessions, nutritional supplements, and vitamins to determine if these can enhance recovery post-surgery. Participants will be divided into two groups: one will follow the prehabilitation program, and the other will receive usual care. This trial targets English-speaking adults with stage II-III rectal cancer planning for surgery who do not already engage in frequent exercise. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve recovery strategies for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the prehabilitation program is safe for rectal cancer patients?

Research shows that exercise is safe and beneficial for people with colorectal cancer. Studies have found that exercise before surgery, known as prehabilitation, is well-tolerated by patients and can improve fitness and aid recovery post-surgery.

A review of studies found that prehabilitation is safe and acceptable for cancer patients before surgery, noting improvements in physical abilities. Another study demonstrated that these exercises could enhance cardiovascular and respiratory efficiency.

Overall, evidence suggests that the prehabilitation program tested in this trial is safe and offers several health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a holistic approach to improving outcomes for rectal cancer patients. Unlike standard treatments that primarily focus on surgery and chemotherapy, the prehabilitation program combines virtual exercise sessions and nutritional supplementation before surgery to boost patients' strength and recovery potential. By focusing on building up patients' physical resilience and nutritional status before the operation, this approach could enhance recovery times and overall well-being, offering a potentially impactful addition to existing care strategies.

What evidence suggests that the prehabilitation program is effective for rectal cancer?

Studies have shown that prehabilitation programs can benefit patients with colorectal cancer, including those with rectal cancer. Research indicates that these programs can lower the risk of post-surgery complications and reduce hospital stays. For example, one study found that patients who underwent prehabilitation had better physical abilities and fewer issues after surgery. Another analysis showed that prehabilitation helped patients recover faster by shortening their hospital stays. In this trial, participants in Group A will receive a Prehabilitation Program, which includes virtual exercise sessions and nutritional supplementation, while Group B will receive usual care. Overall, these findings suggest that prehabilitation might improve outcomes for patients undergoing surgery for rectal cancer. ^{1 4 5 6 7}

Who Is on the Research Team?

Jeffrey A. Meyerhardt

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 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

Currently enrolled in a separate clinical trial that would prohibit them from performing the tasks instructed in this trial

Comorbid conditions or cognitive/physical impairments that contraindicate exercise

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10916464/

A Systematic Review and Meta-Analysis - PubMed Central - NIH This meta-analysis delineated the efficacy of preoperative interventions on postoperative capabilities in patients with colorectal cancer.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S074879832300940X

Prehabilitation in colorectal cancer surgery improves ... Implementation of a multimodal prehabilitation program in colorectal surgery reduces postoperative complication rates, length of stay and hospital costs.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9349170/

Effects and duration of exercise-based prehabilitation in ... Prehabilitation while the patient is preparing to undergo surgery for colorectal carcinoma improves functional capacity; and might reduce postoperative overall ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1619959/full

Multimodal prehabilitation is an effective strategy to reduce ... Secondary outcomes of prehabilitation to postoperative outcomes in colorectal cancer patients. Eight studies with 764 participants showed ...

5. link.springer.com link.springer.com/article/10.1245/s10434-024-15593-2

A Systematic Review of Randomised Controlled Trials The aim of this study was to investigate the effectiveness of prehabilitation in reducing postoperative morbidity and length of hospital stay.

6. mdpi.com mdpi.com/2227-9032/13/9/1083

Multimodal Prehabilitation in Colorectal Cancer: Improving ... Exercise in patients with colorectal cancer is considered a safe option that can provide significant benefits, including increased aerobic capacity ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cam4.4021

Prehabilitation exercise therapy for cancer: A systematic ... Prehabilitation exercise for cancer patients undergoing surgery was found to be safe, acceptable, and feasible with a statistically significant improvement in ...