Studie
Immune-Enhancing Nutrition and Outcomes After Radical Cystectomy: A Randomized Clinical Trial.
A 203-patient phase 3 trial found no 30-day complication reduction from perioperative immunonutrition containing omega-3, arginine and nucleotides.
SWOG S1600 var en multicenterbaserad dubbelblind fas 3-studie vid 13 akademiska sjukhus och sjukhus i lokalsamhället i USA. Den randomiserade 203 vuxna med blåscancer som skulle genomgå radikal cystektomi till vanlig oral nutrition eller en immunnutritionsdryck med tillsatt l-arginin, omega-3-fettsyror och dietära nukleotider. Dryckerna togs tre gånger dagligen i 5 dagar före och efter operationen. The primär endpoint was any 30-day complication of Clavien-Dindo grade 1 or higher. Seventeen participants withdrew and 8 had no 30-day data, leaving 178 evaluable participants: 90 immunonutrition and 88 standard nutrition. Complications occurred in 62.2% of the immunonutrition group and 58.0% of controls (odds ratio 1.18, 95% CI 0.64-2.18). High-grade 30-day complications were 11.1% and 12.5%, respectively (odds ratio 0.86, 95% CI 0.34-2.17). Two-year overall survival was 87.4% versus 78.2%, and disease-free survival was 77.0% versus 67.5%, but neither difference was statistically significant. This well-sized hard-endpoint trial does not show that the multi-ingredient formula reduces postoperative complications. It also cannot isolate any effect of omega-3 fatty acids.
Perioperative specialised immunonutrition did not reduce 30-day complications compared with standard oral nutrition.
The intervention combined omega-3 fatty acids with l-arginine and dietary nucleotides, so it was not an omega-3-only test. It involved people undergoing radical cystectomy, and the survival differences were not statistically significant.
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