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Immune-Enhancing Nutrition and Outcomes After Radical Cystectomy: A Randomized Clinical Trial
Jill M Hamilton-Reeves1, Joseph M Unger2, Jeffrey M Holzbeierlein1
1Department of Urology, University of Kansas Medical Center, Kansas City.
JAMA Network Open
|July 20, 2026
Summary
Perioperative specialized immunonutrition did not reduce 30-day complications after radical cystectomy for bladder cancer. While survival outcomes favored immunonutrition, the differences were not statistically significant.
Area of Science:
- Oncology
- Surgical Nutrition
- Clinical Trials
Background:
- Radical cystectomy for bladder cancer has high complication rates.
- Evidence for perioperative specialized immunonutrition in reducing these complications is limited.
Purpose of the Study:
- To evaluate if perioperative specialized immunonutrition decreases 30-day complications compared to standard nutrition in adults undergoing radical cystectomy.
Main Methods:
- A multicenter, randomized, double-blind, phase 3 clinical trial (SWOG S1600) enrolled 203 adults.
- Participants received either specialized immunonutrition or standard oral nutrition for 5 days before and after surgery.
- Primary outcome was any 30-day complication (Clavien-Dindo grade ≥1); secondary outcomes included survival and adverse events.
Main Results:
- No significant difference in 30-day complications between immunonutrition (62.2%) and standard nutrition (58.0%) groups.
- High-grade 30-day complications were also similar (11.1% vs 12.5%).
- Two-year overall survival (87.4% vs 78.2%) and disease-free survival (77.0% vs 67.5%) favored immunonutrition but were not statistically significant. Adverse events, particularly nausea, were more frequent with immunonutrition.
Conclusions:
- Perioperative specialized immunonutrition did not reduce 30-day complications following radical cystectomy.
- Survival benefits observed require further investigation and mechanistic evaluation.