RecruitingNot ApplicableNCT06069297

Prehabilitation in Pancreatic Surgery

Multimodal Prehabilitation in Localized Pancreatic Cancer Patients Undergoing Surgery: a Randomized Controlled Trial

Sponsor

IRCCS San Raffaele

Enrollment

238 participants

Start Date

Jul 14, 2023

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Frailty Syndrome Perioperative/Postoperative Complications Malnutrition Periampullary Cancer

Summary

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

Min Age: 18 Years

Inclusion Criteria3

Age ≥ 18 years
Indication for curative resection for pancreatic or periampullary cancer
Signed Informed consent

Exclusion Criteria5

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)

Interventions

OTHERMultimodal Prehabilitation

Preoperative 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.