Prehabilitation in Pancreatic Surgery
Recruiting · NCT06069297 · Interventional (participants receive a specific treatment) · Lead sponsor: IRCCS San Raffaele
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Age ≥ 18 years
- Indication for curative resection for pancreatic or periampullary cancer
- Signed Informed consent
Exclusion criteria
- Metastatic or unresectable disease found preoperatively
- Comorbidities contraindicating prehabilitation regimen (exercise and nutritional intervention) such as orthopedic, cognitive disabilities, chronic renal failure (dialysis or creatinine \>250 mmol)
- ASA score 4-5
- Pregnancy
- Illiteracy (inability to read and understand Italian language)
Where it is running
1 location listed.
- San Raffaele Hospital - Milan, Lombardy, Italy