Exercise Prehabilitation for Pancreatic Cancer
(PREHAB Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Cedars-Sinai Medical Center
Disqualifiers: Resection surgery, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to assess the use of an exercise program in people with pancreatic cancer.
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 data supports the effectiveness of the treatment Prehabilitation Program, Exercise Program, Preoperative Rehabilitation, Pre-Surgical Conditioning for pancreatic cancer?
Research shows that prehabilitation, including exercise programs before surgery, can improve physical fitness and reduce complications in patients with pancreatic cancer. Studies found that patients who participated in these programs had better physical function and fewer postoperative complications, which can lead to better overall outcomes.
12345Is exercise prehabilitation safe for people undergoing surgery for pancreatic cancer?
Exercise prehabilitation, including supervised in-hospital and home-based programs, has been shown to be safe for patients undergoing surgery for pancreatic cancer, with no adverse events reported in studies. It can improve physical function and may help prevent serious postoperative complications.
23467How is the Exercise Prehabilitation Program different from other treatments for pancreatic cancer?
The Exercise Prehabilitation Program is unique because it focuses on improving physical fitness before surgery through supervised exercise, which can help reduce postoperative complications and improve recovery, unlike traditional treatments that primarily focus on the cancer itself.
23478Eligibility Criteria
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
+6 more
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.
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Supervised Prehabilitation Exercise ProgramExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cedars-Sinai Medical CenterLos Angeles, CA
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Who Is Running the Clinical Trial?
Cedars-Sinai Medical CenterLead Sponsor
References
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. [2023]To determine the effects of a preoperative, home-based exercise program on fitness and physical function in patients with pancreatic cancer.
Prehabilitation prior to surgery for pancreatic cancer: A systematic review. [2021]Prehabilitation aims to improve fitness and outcomes of patients undergoing major surgery. This systematic review aimed to appraise current available evidence regarding the role of prehabilitation in patients undergoing oncological pancreatic resection.
Preoperative In-Hospital Rehabilitation Improves Physical Function in Patients with Pancreatic Cancer Scheduled for Surgery. [2021]Low preoperative physical function in cancer patients is associated with postoperative complications; however, there have been no reports on the benefits of in-hospital preoperative rehabilitation on preoperative physical function in patients with pancreatic cancer. Therefore, the aim of this study was to quantitatively determine the effects of preoperative in-hospital rehabilitation provided under the supervision of a physiotherapist, on preoperative physical function in patients with pancreatic cancer. The study subjects were 26 patients (15 males, 11 females; age 71.2 ± 8.5 years, range: 51-87 years), including four patients with preoperative chemotherapy, scheduled for surgery for pancreatic cancer. Muscle strengthening exercises and aerobic exercises were conducted 11.9 ± 5.1 days prior to surgery. Cardiopulmonary exercise testing, 6-minute walk distance, and the Functional Independence Measure score were measured before and after the rehabilitation program. We also investigated the relation between the rehabilitation program and incidence of postoperative complications. All 26 study patients completed the preoperative rehabilitation program and no adverse events were noted. Peak oxygen uptake during cardiopulmonary exercise testing and 6-minute walk distance increased significantly after the rehabilitation program. The Functional Independence Measure score remained constant throughout the intervention. No wound infection, delirium, deep vein thrombosis, or respiratory complications were encountered postoperatively. In-hospital preoperative rehabilitation under the supervision of a physiotherapist significantly improved physical function and maintained physical activity in patients with pancreatic cancer. Such improvements may contribute toward preventing serious postoperative complications, resulting in better outcomes.
Supervised Home-Based Exercise Prehabilitation in Unfit Patients Scheduled for Pancreatic Surgery: Protocol for a Multicenter Feasibility Study. [2023]Morbidity rates in pancreatic surgery are high, and frail patients with low aerobic capacity are especially at risk of complications and require prophylactic interventions. Previous studies of small patient cohorts receiving intra-abdominal surgery have shown that an exercise prehabilitation program increases aerobic capacity, leading to better treatment outcomes.
The Impact of Prehabilitation on Patient Outcomes in Hepatobiliary, Colorectal, and Upper Gastrointestinal Cancer Surgery: A PRISMA-Accordant Meta-analysis. [2023]To determine the impact of prehabilitation on hospital length of stay, functional capacity, complications, and mortality after surgery in patients with hepatobiliary, colorectal, and upper gastrointestinal cancer.
Personalized community-based prehabilitation for a high-risk surgical patient opting for pylorus-preserving pancreaticoduodenectomy: a case report. [2021]Introduction: Prehabilitation aims for an optimal physical functioning level before, during, and after hospitalization for major surgery. The purpose of this case report was to illustrate the care pathway of a high-risk patient who opted for pylorus-preserving pancreaticoduodenectomy, including preparation for this procedure by participating in a community-based exercise prehabilitation program. The report describes patient examination, evaluation in decision-making for surgery, the prehabilitation program, and outcomes within the context of the Hypothesis-Oriented Algorithm for Clinicians II.Case Description: The patient was a 75-year-old woman with a history of several comorbidities and a polypoid mass in the descending segment of the duodenum. Based on the preoperative assessment, the level of physical functioning was expected to be insufficient to cope adequately with the stress of hospitalization and surgery.Intervention: A 4-week prehabilitation program, including aerobic, resistance, and functional task training in a community-based physical therapy practice.Outcomes: Prehabilitation had a beneficial impact on improving functional mobility preoperatively (timed up-and-go test score improved from 19.4 to 10.0 s, five times sit-to-stand test score improved from 30.1 to 10.1 s, and two-minute walk test distance improved from 55.0 to 107.0 m). Surgery and postoperative recovery proceeded without complications. She achieved independent physical functioning on postoperative day 6 and was discharged home on postoperative day 12.Conclusion: Preoperative risk-assessment can support clinical decision-making in a high-risk patient opting for major abdominal surgery. Furthermore, a remarkable improvement in physical functioning can be achieved by community-based prehabilitation in a high-risk surgical patient.
Home-based exercise during preoperative therapy for pancreatic cancer. [2023]Exercise concurrent with neoadjuvant chemotherapy and/or chemoradiation for pancreatic adenocarcinoma (PDAC) may mitigate the decline in function that may occur as a result of the disease or its treatment in the preoperative period. The primary objective of this single-arm prospective trial was to determine adherence to a home-based exercise program administered during preoperative therapy.
Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. [2023]Prehabilitation programs focusing on exercise training as the main component are known as a promising alternative for improving patients' outcomes before cancer surgery. This systematic review determined the benefits and harms of prehabilitation programs compared with usual care for individuals with cancer.