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

Recruiting now · Phase 3

Conditions studied: Bladder Cancer, Interstitial Cystitis, Painful Bladder Syndrome, Neurogenic Bladder, Hemorrhagic Cystitis, Endometriosis, Bladder Disease

In brief

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.

Key facts

Study ID

NCT05726786

Run by

Centre Hospitalier Universitaire Vaudois

People needed

232

Starts

2023-04-10

Expected to finish

2026-10-01

Last updated by the study team

2025-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient undergoing open cystectomy (for all reasons)
• Age ≥18 years
• Ability and willingness to provide informed consent documented by signature

You may not qualify if…

• Contraindications to IN, e.g. known hypersensitivity or allergy to lactose, fish oil or soy lecithin
• Severe diarrhoea requiring medical attention
• Current treatment with any immunosuppressive drug
• In standard practice, pregnant or lactating women are systematically rejected by the surgeon for this surgical procedure. Furthermore, during the pre-surgical anaesthesia consultation, the eligibility of each patient for anaesthesia will be assessed according to the usual criteria and recommendations of the anaesthesia service of the CHUV
• Other clinically significant concomitant disease affecting immunity (e.g., severe renal failure, HIV, SLE, transplant recipient, ...)
• Inability to follow the procedures of the study, e.g. due psychological disorders, dementia, etc.
• Participation in another study with investigational drug within the 30 days preceding and during the present study
• Previous enrolment into the current study
• Use of IN independently of the study
• Enrolment of the investigator, his/her family members, employees and other dependent persons
• Emergency procedure (less than 7 days between screening and surgery)

Where it is running

• Centre Hospitalier Universitaire Vaudois, CHUV — Lausanne, Canton of Vaud, Switzerland (enrolling)
• University Hospital of Bern — Bern, Switzerland (enrolling)
• University Hospital of Geneva — Geneva, Switzerland (enrolling)
• Hospital of Riviera-Chablais — Rennaz, Switzerland (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.