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Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06069297

Randomized Trial of a Four-Week Multimodal Prehabilitation Program Before Surgery for Localized Pancreatic and Periampullary Cancer

Led by IRCCS San Raffaele · Updated on 2025-08-01

238

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a four-week multimodal prehabilitation program on patients with localized pancreatic or periampullary cancer who are scheduled for curative surgery. This trial aims to improve postoperative outcomes by addressing common risk factors such as older age, frailty, multiple health conditions, and malnutrition. The study also explores how prehabilitation influences biomarkers linked to muscle wasting and cancer cachexia in pancreatic ductal adenocarcinoma PDAC patients. Participants will be randomly assigned to either the intervention group, receiving a supervised multimodal prehabilitation program including physical exercise, nutritional support, and psychosocial counseling for at least four weeks before surgery, or to a control group receiving usual care with educational materials about healthy lifestyle and surgery preparation. Both groups will undergo the same surgical and postoperative care based on enhanced recovery protocols. During the study, patients will undergo baseline assessments of medical history, physical performance, nutritional status, body composition, autonomic nervous system activity, and quality of life through various tests and questionnaires. These evaluations will be repeated before surgery and at 30, 60, and 90 days after surgery to monitor recovery, functional capacity, nutritional status, body composition, psychological well-being, and complications. Blood samples will be collected to analyze inflammatory and cachexia-related factors. The study includes follow-up visits and phone contacts to track patient progress over time.

CONDITIONS

Brief Title

Prehabilitation in Pancreatic Surgery

Research Team

N

Nicolò Pecorelli, MD

F

Francesca Di Salvo, PhD

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