The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)

Phase 3 Recruiting 232 enrolled Centre Hospitalier Universitaire Vaudois Hôpital Riviera-Chablais, Vaud-Valais · collab Insel Gruppe AG, University Hospital Bern · collab University Hospital, Geneva · collab

RandomizedParallel-groupOpen-labelSupportive care

Summary

The goal of this clinical trial research study is to evaluate the impact of preoperative oral immunonutrition (IN) on post-operative complications in patients undergoing a cystectomy. As a secondary focus, this study will aim to develop a signature that would identify patients that would benefit the most from IN. This is a multicentric (Swiss: N=3), prospective, controlled, pragmatic, parallel-group comparative study with block randomization stratified by centers.

Timeline

Start: 2023-04-10
Primary completion: 2026-08
Completion: 2026-10

Publications

Derre L, Crettenand F, Grilo N, Stritt K, Kiss B, Tawadros T, Domingos-Pereira S, Roth B, Cerantola Y, Lucca I. The role of preoperative immunonutrition on morbidity and immune response after cystectomy: protocol of a multicenter randomized controlled trial (INCyst Trial). Trials. 2024 Oct 17;25(1):687. doi: 10.1186/s13063-024-08536-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oral Impact®	Other / unclassified	—	Oral

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)

Summary

Timeline

Publications

Drugs

Indications