Immune-Enhancing Nutrition and Outcomes After Radical Cystectomy: A Randomized Clinical Trial
Abstract
Importance: Radical cystectomy for bladder cancer is associated with high complication rates. Evidence supporting perioperative specialized immunonutrition for reducing complications is limited.
Objective: To determine whether perioperative specialized immunonutrition reduces 30-day complications compared with standard oral nutrition support among adults undergoing radical cystectomy.
Design, setting, and participants: This multicenter, randomized, double-blind, phase 3 clinical trial (SWOG S1600) conducted at 13 US academic and community sites within the National Cancer Institute National Clinical Trials Network and National Community Oncology Research Program enrolled patients from March 5, 2019, through October 19, 2023, with 30-day complications assessed through day 90 and survival outcomes through 2 years. Participants included adults with bladder cancer scheduled for radical cystectomy who could swallow oral liquids and did not have severe malnutrition. Statistical analysis was performed from January 2024 to December 2026.
Interventions: Participants consumed drinks 3 times daily for 5 days before and after surgery. Both drinks used the same base formula. The immunonutrition product contained added l-arginine, ω-3 fatty acids, and dietary nucleotides. Adherence was 94.5% (52 of 55), measured using the plasma arachidonic acid to eicosapentaenoic acid biomarker.
Main outcomes and measures: Analysis was performed on a modified intent-to-treat basis. The primary outcome…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 203 participants or records.
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