Immunonutrition to improve the quality of life of upper gastrointestinal cancer patients undergoing neoadjuvant treatment prior to surgery (NEOIMMUNE): double-blind randomized controlled multicenter clinical trial

Background: Malnutrition is common with esophagogastric cancers and is associated with negative outcomes. We aimed to evaluate if immunonutrition during neoadjuvant treatment improves patient’s health-related quality of life (HRQOL) and reduces postoperative morbidity and toxicities during neoadjuvant treatment. Methods: A multicenter double-blind randomized controlled trial (RCT) was undertaken. Included patients had untreated nonmetastatic esophagogastric tumor, aged 18 ≥ years with a life expectancy of >3 months. The study was powered for 80% power to detect a clinically relevant difference in EORTC-QLQC30 with standard deviation of 15 between groups. Primary end point was the quality of life as measured by the global health status at 30 days after surgery. An intention-to-treat analysis was employed. Results: The study was terminated at the interim analysis stage. About 300 patients were randomized: 149 to the IMPACT group and 151 to the control-formula group. Patient groups were well-balanced in terms of age, sex, body mass index, WHO performance status, and clinical tumor stage. Analysis of the primary end point for the study of global health status at 30-day postoperatively failed to show any significant differences between the groups (55.4 ± 18.6 [IMPACT] vs. 55.9 ± 19.8 [control]; P = 0.345). No significant differences between the groups were detected in the majority of domains from EORTC QLQC30 and OG25 tools after neoadjuvant therapy and 30 days postoperatively. Finally, no significant differences were seen between groups in neoadjuvant therapy or postoperative complications, or tumor response. Conclusion: The results of this multicenter double-blind RCT fail to demonstrate any HRQOL benefits to the utilization of immunonutrition during neoadjuvant therapy in patients with esophagogastric cancer.