Pancreatic cancer.
Jonathan D Mizrahi, Rishi Surana, Juan W Valle...
https://pubmed.ncbi.nlm.nih.gov/32593337Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06069297
Multimodal Prehabilitation in Localized Pancreatic Cancer Patients Undergoing Surgery: a Randomized Controlled Trial
Led by IRCCS San Raffaele · Updated on 2025-08-01
238
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
IRCCS San Raffaele
Lead Sponsor
M
Ministero della Salute, Italy
Collaborating Sponsor
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for curative surgery for pancreatic or periampullary cancer
- Signed informed consent
You will not qualify if you...
- Metastatic or unresectable disease found before surgery
- Comorbidities preventing exercise or nutritional interventions such as orthopedic or cognitive disabilities or severe kidney failure
- ASA score of 4 or 5
- Pregnancy
- Inability to read and understand Italian language (illiteracy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Preoperative Assessment and Baseline Measurements
Duration - 1 day
Participants undergo comprehensive baseline evaluations including medical history, physical performance tests, nutritional assessments, body composition measurements, autonomic nervous system activity, patient-reported outcome questionnaires, and blood sample analysis.
1 visit (in-person)
Multimodal Prehabilitation or Usual Care
Duration - 4 to 6 weeks
Participants are randomized to receive either a 4 to 6-week multimodal prehabilitation program including exercise training, nutritional therapy, and psychosocial counseling, or usual preoperative care with informative material. This aims to improve functional capacity and prepare participants for surgery.
Exercise sessions 2 to 3 times per week plus nutritional and psychological counseling visits during this period
Pre-surgery Re-evaluation
Duration - 1 day
One day before surgery, participants repeat the baseline assessments to evaluate functional capacity, nutritional status, body composition, quality of life, and related measures.
1 visit (in-person)
Surgery and Hospital Stay
Duration - Variable depending on hospital stay
Participants undergo pancreatic surgery followed by hospital stay where postoperative outcomes and complications are monitored and recorded.
Routine hospital visits during inpatient stay
Postoperative Follow-up and Recovery
Duration - 90 days
Participants are followed up at 30, 60, and 90 days after surgery during scheduled outpatient visits to assess recovery, including functional capacity, nutritional status, body composition, quality of life, anxiety and depression, and patient engagement.
3 outpatient visits at 30, 60, and 90 days post-surgery plus phone calls from nurse navigator
Trial Site Locations
Total: 1 location
1
San Raffaele Hospital
Milan, Lombardy, Italy, 20132
Actively Recruiting
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Research Team
N
Nicolò Pecorelli, MD
F
Francesca Di Salvo, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
The Impact of Prehabilitation on Patient Outcomes in Hepatobiliary, Colorectal, and Upper Gastrointestinal Cancer Surgery: A PRISMA-Accordant Meta-analysis.
Joel E Lambert, Lawrence D Hayes, Thomas J Keegan...
https://pubmed.ncbi.nlm.nih.gov/33201129Validation of the PROMIS-29 Questionnaire as a Measure of Recovery After Pancreatic Surgery.
Nicolò Pecorelli, Giovanni Guarneri, Alessia Vallorani...
https://pubmed.ncbi.nlm.nih.gov/37465965Multimodal Prehabilitation In Pancreatic cancer Patients undergoing surgery (PIPS): study protocol for a randomized controlled trial.
Nicolò Pecorelli, Francesca Fermi, Martina Abati...
https://pubmed.ncbi.nlm.nih.gov/41618415