IMMUNONUTRITION did not reduce 30 day postoperative complications compared with standard oral nutrition support in adults undergoing radical cystectomy for bladder cancer, according to findings from a multicentre randomised clinical trial.
Radical cystectomy is associated with high rates of postoperative complications, prompting interest in perioperative nutritional strategies that may improve recovery. Researchers conducted a multicentre, randomised, double blind, Phase III clinical trial to evaluate whether specialised immunonutrition could reduce complications following surgery compared with standard isocaloric oral nutrition support.
The study enrolled 203 adults with bladder cancer scheduled for radical cystectomy between 2019–2023. Participants consumed nutritional drinks three times daily for 5 days before and after surgery. The immunonutrition formulation contained added l-arginine, omega 3 fatty acids, and dietary nucleotides, while the control drink used the same base formula without these additions. After withdrawals and missing outcome data, 178 patients were included in the primary analysis.
Thirty Day Outcomes Were Similar
At 30 days, at least one postoperative complication occurred in 62.2% of patients receiving immunonutrition compared with 58.0% of those receiving standard nutrition (odds ratio:1.18; 95% CI:0.64–2.18). The difference was not statistically significant.
Rates of high grade complications were also comparable between groups. High grade complications occurred in 11.1% of patients receiving immunonutrition and 12.5% of those receiving standard nutrition (odds ratio:0.86; 95% CI:0.34–2.17).
Adverse events were reported more frequently among patients receiving immunonutrition, occurring in 34.1% compared with 20.5% of patients receiving standard nutrition. Nausea was the most commonly reported adverse event. Adherence to the nutritional intervention was high, with compliance confirmed in 94.5% of assessed participants.
Longer Term Outcomes Need Further Study
Although the primary endpoint was not met, two year survival outcomes numerically favoured immunonutrition. Overall survival was 87.4% in the immunonutrition group compared with 78.2% in the standard nutrition group, while disease free survival was 77.0% and 67.5%, respectively. However, these differences were not statistically significant.
The authors concluded that perioperative immunonutrition did not reduce early postoperative complications following radical cystectomy compared with standard oral nutrition support. They suggested that further mechanistic studies and subgroup analyses are needed to determine whether specific patient populations may benefit from specialised nutritional interventions.
Reference
Hamilton-Reeves JM et al. Immune-enhancing nutrition and outcomes after radical cystectomy: a randomized clinical trial. JAMA Netw Open. 2026; 9;(7):e2623622.
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