Actively Recruiting
Prehabilitation in Pancreatic Surgery
Led by IRCCS San Raffaele · Updated on 2025-08-01
238
Participants Needed
1
Research Sites
202 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
In patients with pancreatic cancer, older age, multiple comorbidities, frailty, malnutrition and poor functional status are common, especially in individuals receiving neoadjuvant chemotherapy. These characteristics represent potentially modifiable risk factors for poor postoperative outcomes. The goal of this clinical randomized controlled trial is to evaluate the extent to which a four-week multimodal prehabilitation program impacts on postoperative morbidity, functional and nutritional status and health-related quality of life in patients with localized pancreatic or periampullary cancer scheduled for curative surgery. In addition, the impact of prehabilitation on circulating sarcopenia and cancer cachexia biomarkers in PDAC patients will be explored. Included patients will be randomized (ratio 1:1) and allocated either to the intervention group (Multimodal Prehabilitation), which will receive prehabilitation, or to the control group, which will receive no prehabilitation.
CONDITIONS
Official Title
Prehabilitation in Pancreatic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for curative surgery for pancreatic or periampullary cancer
- Signed informed consent to participate in the study
You will not qualify if you...
- Presence of metastatic or unresectable disease before surgery
- Health conditions preventing participation in exercise or nutritional interventions, such as orthopedic or cognitive disabilities, or chronic renal failure requiring dialysis or with creatinine >250 mmol
- ASA (American Society of Anesthesiologists) physical status score of 4 or 5
- Pregnancy
- Illiteracy or inability to read and understand the Italian language
AI-Screening
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Trial Site Locations
Total: 1 location
1
San Raffaele Hospital
Milan, Lombardy, Italy, 20132
Actively Recruiting
Research Team
N
Nicolò Pecorelli, MD
CONTACT
F
Francesca Di Salvo, PhD
CONTACT
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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