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.
Age ≥ 18 years
Indication for curative resection for pancreatic or periampullary cancer
Signed Informed consent
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
Parallel
Multimodal Prehabilitation
Other interventionPreoperative multimodal intervention including exercise training, nutritional therapy and psychosocial counseling, aimed at preventing or attenuating surgery-driven functional decline. A personalized intervention program will be prescribed based on specific physical, nutritional and psychological conditions recognized during the multimodal assessment. Patients will follow a 2 to 3-day per week exercise program for 4-6 weeks including endurance, resistance, and inspiratory muscle training, tailored to individual preferences and clinical conditions. Based on dietary habits and nutritional status, a certified nutritionist will provide a comprehensive diet management program. A food-based intervention with a balanced macronutrient composition coupled with oral nutritional supplements will be prescribed to achieve the estimated daily energy and protein requirements. Patients will meet with a psychologist to explore their emotional and psychosocial needs related to their current situation.
Comprehensive Complication Index (CCI)
Postoperative complications occurring during the index admission or in a subsequent readmission, when related to surgery, will be recorded up to 90 days after surgery and graded by severity using the Dindo-Clavien classification and the Comprehensive Complication index (CCI). The Dindo-Clavien system grades complications according to the therapy needed for treatment: Grade I, are complications that require bedside management; Grade II, are complications that require pharmacologic treatment; Grade III, are complications that require surgical or radiologic intervention and; Grade IV, are complications that require intensive care treatment. Dindo-Clavien Grade III or above are considered severe postoperative complications. The CCI, derived from the Dindo-Clavien system, is a validated metric summarizing the complete spectrum of complications that occurred and their severity in a single score ranging from 0 to 100.
Time to patient functional recovery (TFR)
TFR will be measured by subtracting the date of surgery from the date when participants achieve standardized criteria (tolerance of oral intake, recovery of lower gastrointestinal function, adequate pain control on oral analgesia, ability to mobilize and self-care and no evidence of untreated medical problems)
Lenght of stay (LOS)
LOS will be measured by subtracting the date of surgery from the date of discharge
Functional capacity
Functional capacity will be measured by the 6-minute walking test, timed up and go test (TUG), gait speed assessment, handgrip strength test, and compared between groups on the day before surgery, at 30-60-90 days after surgery.
Nutritional status
Nutritional status will be measured by weight (kg), height (cm), and body mass index (kg/m2), and nutritional screening questionnaires (mini nutritional assessment - MNA, patient-generated - subjective global assessment - PG-SGA) and compared between groups at baseline, on the day before surgery, at 30, 60, 90 days after surgery..
Hospital costs
Hospital-related costs will be collected for all patients included in the study over a 90-day postoperative period. These costs include expenses directly associated with patient care, such as the prehabilitation program (staff time, facilities, equipment, and sessions), surgical procedures, length of hospital stay, management of complications, remissions, and follow-up visits within 90 days after surgery. Comparing hospital costs between patients receiving prehabilitation and those undergoing standard care will provide valuable insight into the economic impact of prehabilitation on healthcare resource utilization during the early postoperative period.
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IRCCS San Raffaele
Lead sponsor
Ministero della Salute, Italy
Collaborator
