Study of Peptamen 1.6 Versus Resource HPHC Nutrition in Malnourished or At-Risk Adults with Pancreatic Cancer After Cephalic Pancreaticoduodenectomy

What this Trial Is About

Malnutrition is a frequent challenge for patients with pancreatic cancer undergoing cephalic pancreaticoduodenectomy CPD, which can affect their recovery and overall outlook. Researchers are studying the effects of two different nutritional formulas, Peptamen 1.6, a hydrolysed whey protein-based enteral formula, and Resource HPHC, a high-protein, high-calorie polymeric formula, in malnourished or at-risk patients with pancreatic cancer who have undergone CPD. This randomized, double-blind, crossover trial includes both patient-based and laboratory analyses to better understand nutritional impacts. Participants receive either Peptamen 1.6 or Resource HPHC in a crossover design, with a one-week washout period between formulas. The study evaluates how these nutritional supplements influence digestive tolerance, amino acid absorption, metabolic and inflammatory markers, nutritional status, and gut microbiota. In vitro studies using human intestinal organoid models will also explore the effects of these formulas on intestinal permeability and metabolism, focusing on microbiota interactions. During the study, participants will be closely monitored at several time points including baseline, weeks 6, 7, and 13. Assessments include blood tests for metabolic and inflammatory markers, stool samples for microbiota analysis, body composition measurements by bioelectrical impedance, dynamometry for muscle strength, functional mobility tests, and abdominal ultrasounds. The study also tracks adherence to the nutritional treatment, digestive tolerance, symptoms of anxiety and depression, and changes in natural food intake to comprehensively evaluate the effects of the nutritional interventions.

Effects of Peptamen 1.6 in Malnourished Patients (or at Risk) With Pancreatic Neoplasia Undergoing Cephalic Pancreaticoduodenectomy (CPD): A Mechanistic Study