Prehabilitation in Pancreatic Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS San Raffaele

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Indication for curative resection for pancreatic or periampullary cancer

Signed Informed consent

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Multimodal Prehabilitation

Treatment groups

238 Participants
are divided into 2 treatment groups

Sponsors and collaborators

IRCCS San Raffaele

Lead sponsor

Ministero della Salute, Italy

Collaborator