Exercise Prehabilitation for Pancreatic Cancer

(PREHAB Trial)

Overseen By Philip Chang, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Resection surgery, Pregnancy, others

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

Compensation: Varies

Number of Visits: 21

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how an exercise program can benefit people with pancreatic cancer. The focus is on determining if exercise can improve health and well-being before any major treatment. Participants will engage in a supervised exercise program, known as a Prehabilitation Program, to assess its impact on physical fitness and overall health. Individuals diagnosed with pancreatic cancer who can walk independently might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to enhance health and well-being through exercise before beginning major treatments.

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 study team or your doctor.

What prior data suggests that this exercise program is safe for people with pancreatic cancer?

Research has shown that the exercise program before surgery is safe for people with pancreatic cancer. One study found that participants experienced no harmful side effects during the program. The exercise also improved their physical abilities, potentially leading to better recovery after surgery. Overall, these findings suggest that participants tolerate the program well and that it is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exercise Prehabilitation Program for pancreatic cancer because it introduces a proactive approach to patient care. Unlike traditional treatments that focus solely on surgery, chemotherapy, or radiation, this program emphasizes physical fitness and strength-building before medical procedures. The unique feature of this program is its supervised exercise component, which aims to enhance patients' physical resilience and potentially improve surgical outcomes and recovery times. This proactive strategy could lead to better overall health and quality of life for patients facing this challenging condition.

What evidence suggests that this prehabilitation program is effective for pancreatic cancer?

Research shows that exercise programs before surgery, known as prehabilitation, can benefit people with pancreatic cancer. In this trial, participants will engage in a Supervised Prehabilitation Exercise Program. Studies have found that these programs may improve physical fitness and reduce complications after surgery. Early evidence suggests that prehabilitation can enhance recovery and increase strength before surgery. Specifically, patients have experienced significant improvements in physical function with prehabilitation, leading to better outcomes after surgery. Overall, this approach aims to strengthen patients and improve recovery when facing pancreatic surgery. ^{2 3 6 7 8}

Who Is on the Research Team?

Philip Chang, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with pancreatic cancer who can walk and do daily activities on their own. They must be able to perform certain physical tests, have no major restrictions on exercise from their doctor, give written consent, and use a smart device for activity tracking. People who've had or will have surgery before the program ends, are pregnant, or use certain electronic medical devices can't join.

Inclusion Criteria

I can perform physical tests like walking, gripping, and other short exercises.

I have been diagnosed with pancreatic cancer.

Answers no to all questions on PAR-Q OR is cleared to participate by their treating oncologist

Exclusion Criteria

I will have surgery before finishing the PREHAB exercise program.

Current pregnancy

You have an implanted device like a pacemaker, defibrillator, or neurostimulator, unless the study doctor says it's okay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants engage in a supervised, in-person exercise program 3 times per week

6 weeks

18 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the exercise program

3 months

Post-Intervention Evaluation and 3-Month Follow Up

What Are the Treatments Tested in This Trial?

Interventions

• Prehabilitation Program

Trial Overview

The study is testing an exercise program called PREHAB for people with pancreatic cancer. It aims to see if this supervised prehabilitation helps improve patients' fitness levels and overall well-being before they undergo any other treatments.

How Is the Trial Designed?

Group I: Supervised Prehabilitation Exercise Program Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

In-hospital preoperative rehabilitation for pancreatic cancer patients, involving muscle strengthening and aerobic exercises, significantly improved physical function, as evidenced by increased peak oxygen uptake and 6-minute walk distance after the program.

The rehabilitation program was safe, with no adverse events reported, and it may help prevent serious postoperative complications, contributing to better surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative In-Hospital Rehabilitation Improves Physical Function in Patients with Pancreatic Cancer Scheduled for Surgery. Mikami, Y., Kouda, K., Kawasaki, S., et al.[2021]

This multicenter study is assessing the feasibility of a 4-week home-based exercise prehabilitation program for 30 unfit patients scheduled for pancreatic surgery, focusing on improving their aerobic capacity and functional mobility.

The program includes high-intensity interval training and functional exercises, aiming to enhance patient outcomes and potentially reduce complications in this high-risk group, with results expected to inform future prehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised Home-Based Exercise Prehabilitation in Unfit Patients Scheduled for Pancreatic Surgery: Protocol for a Multicenter Feasibility Study. Hildebrand, ND., Wijma, AG., Bongers, BC., et al.[2023]

A 75-year-old high-risk patient improved her physical functioning significantly through a 4-week community-based prehabilitation program, which included aerobic and resistance training, before undergoing major surgery.

The patient experienced a smooth surgical recovery without complications, achieving independent physical functioning just 6 days post-surgery, highlighting the effectiveness of prehabilitation in enhancing outcomes for high-risk surgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized community-based prehabilitation for a high-risk surgical patient opting for pylorus-preserving pancreaticoduodenectomy: a case report. A van Beijsterveld, C., Bongers, BC., den Dulk, M., et al.[2021]

In a study involving 20 patients with potentially resectable pancreatic adenocarcinoma, 75% adhered to a home-based exercise program during preoperative chemotherapy, reporting an average of 156 minutes of exercise weekly.

The exercise program was safe, with no adverse events reported, and significantly increased physical activity levels in patients who initially had low baseline activity, suggesting that exercise can be effectively integrated into treatment for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise during preoperative therapy for pancreatic cancer. Ngo-Huang, A., Parker, NH., Wang, X., et al.[2023]

Prehabilitation, which includes exercise, nutrition, and psychosocial support, significantly reduced hospital length of stay by an average of 1.78 days for patients undergoing cancer surgery, based on a meta-analysis of 15 studies involving various cancer types.

However, prehabilitation did not show any significant impact on functional capacity, postoperative complications, or mortality rates, suggesting its primary benefit lies in speeding up recovery rather than improving overall surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Prehabilitation on Patient Outcomes in Hepatobiliary, Colorectal, and Upper Gastrointestinal Cancer Surgery: A PRISMA-Accordant Meta-analysis. Lambert, JE., Hayes, LD., Keegan, TJ., et al.[2023]

A randomized trial involving 151 patients with pancreatic cancer showed that both a prescribed exercise program and enhanced usual care led to significant improvements in walking distance, with Arm B (exercise) showing a greater mean increase of 27.3 meters compared to 18.6 meters in Arm A (usual care).

While both groups had similar overall activity levels, Arm B participants increased their strength training sessions significantly more, indicating that a structured exercise program can enhance physical fitness in patients preparing for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Pragmatic Home-based Exercise Program Concurrent With Neoadjuvant Therapy on Physical Function of Patients With Pancreatic Cancer: The PancFit Randomized Clinical Trial. Ngo-Huang, AT., Parker, NH., Xiao, L., et al.[2023]

A systematic review of 25 randomized-controlled trials involving 2682 cancer patients found that prehabilitation programs focusing on exercise training did not show clear benefits over usual care in improving health-related quality of life or reducing postoperative complications.

The overall certainty of the evidence was assessed as very low due to serious methodological concerns, indicating that more research is needed to determine the true effectiveness of prehabilitation programs for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. Meneses-Echavez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

Prehabilitation programs before pancreatic surgery can improve postoperative outcomes, such as reducing delayed gastric emptying and shortening hospital stays, based on a systematic review of six studies involving 193 patients.

Supervised exercise programs showed better adherence and effectiveness in improving muscle mass and function compared to unsupervised programs, highlighting the importance of structured prehabilitation in enhancing recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation prior to surgery for pancreatic cancer: A systematic review. Bundred, JR., Kamarajah, SK., Hammond, JS., et al.[2021]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32826168/

Prehabilitation prior to surgery for pancreatic cancer

Early evidence demonstrates that Prehabilitation programmes may improve postoperative outcomes following pancreatic surgery.

2.

withpower.com

withpower.com/trial/phase-pancreatic-neoplasms-3-2023-8fbec

Exercise Prehabilitation for Pancreatic Cancer (PREHAB ...

Research shows that prehabilitation, including exercise programs before surgery, can improve physical fitness and reduce complications in patients with ...

3.

consultqd.clevelandclinic.org

consultqd.clevelandclinic.org/maximizing-prehabilitations-potential-before-pancreatic-surgery

Maximizing Prehabilitation's Potential Before Pancreatic Surgery

A pilot prehabilitation program intended to boost pancreatic cancer patients' strength before resection surgery and improve their postoperative outcomes

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06069297

NCT06069297 | Prehabilitation in Pancreatic Surgery

The goal of this clinical randomized controlled trial is to evaluate the extent to which a four-week multimodal prehabilitation program impacts on postoperative ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7050956/

Home-Based Exercise Prehabilitation During Preoperative ...

Conclusions: Patients with potentially resectable pancreatic cancer exhibit meaningful improvement in physical function with prehabilitation; physical activity ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05692323

A Supervised Prehabilitation Program for Patients With ...

Study Overview. Brief Summary. The purpose of this study is to assess the use of an exercise program in people with pancreatic cancer.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8487197/

Pre-admission interventions (prehabilitation) to improve ...

To determine the benefits and harms of pre-admission interventions (prehabilitation) on postoperative outcomes in patients undergoing major elective surgery.

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bmjopen.bmj.com

bmjopen.bmj.com/content/15/7/e093832

An assessment of study characteristics, quality and ...

This scoping review describes the characteristics and quality of reporting of prehabilitation exercise interventions for adults living with cancer.