A randomized phase III double-blind clinical trial (S1600) evaluating the effect of immune-enhancing nutrition on radical cystectomy outcomes.

Abstract

TPS529 Background: This phase III trial will compare the impact of consuming Specialized IMmunonutrition (SIM) to oral nutritional support on postoperative complications after radical cystectomy. Specialized IMmunonutrition is fortified with nutrients (L-arginine, omega-3 fatty acids, dietary nucleotides, and vitamin A) that have immediate effects on immune and inflammatory responses, muscle sparing, and wound healing after surgery. Methods: Two hundred patients will be randomized in a 1:1 fashion to one of two arms. Subjects will be stratified by diversion type (neobladder vs. ileal conduit) and whether the patient had neoadjuvant chemotherapy (any vs. none) to balance the intervention assignment according to important prognostic factors. Nutrition drinks are given three times a day for 5 days before and 5 days after surgery. The primary endpoint is 30 day overall complication rate. Two hundred patients gives 80% power to detect an absolute reduction of 23% in the 30 day overall complication rate (from 65% down to 42%). Secondary endpoints will assess infections, muscle mass, readmissions, quality of life, recurrence, DFS, OS, immune response, cytokines, amino acids, and fatty acids. The trial is testing a high yield, low-risk, low-cost strategy to improve the outcome of patients with bladder cancer who undergo cystectomy. Funding: NIH/NCI/DCP grant award UG1CA189974. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.