ASCO GU 2018: A Randomized Phase III Double-Blind Clinical Trial (S1600) Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes

San Francisco, CA ( This phase III trial will compare the impact of consuming Specialized IMmuno-nutrition (SIM) to oral nutritional support on postoperative complications after radical cystectomy. SIM is fortified with nutrients (L-arginine, omega-3 fatty acids, dietary nucleotides, and vitamin A), that have been shown to have immediate effects on immune and inflammatory responses, muscle sparing, and wound healing after surgery.

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. The trial has an 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, disease free survival, overall survival, 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. The trial is funded by the NIH/NCI/DCP grant award UG1CA189974. 

Presented by: Jill Hamilton-Reeves, University of Kansa Medical Center

Co-Authors: Jeffrey M. Holzbeierlein, Joseph M. Unger, Danika L Lew, Michael Jordan Fisch, Norah Lynn Henry; University of Kansas Medical Center, Kansas City, KS; Fred Hutchinson Cancer Research Center, Seattle, WA; SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA; AIM Specialty Health, Chicago, IL; University of Utah, Salt Lake City, UT

Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at the 2018 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, February 8-10, 2018 - San Francisco, CA