NCT05726786RecruitingPhase 3
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 232 (estimated)
- First submitted
- 16 Jan 2023
- Start date
- 10 Apr 2023
- Primary completion date
- Aug 2026
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Diseases
- Bladder cancer, Endometriosis
- NCT number
- NCT05726786
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 232
- From 10 Apr 2023 to the primary completion date, Aug 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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, ...)
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Previous enrolment into the current study
- Emergency procedure (less than 7 days between screening and surgery)
Other illness
- Contraindications to IN, e.g. known hypersensitivity or allergy to lactose, fish oil or soy lecithin
- Inability to follow the procedures of the study, e.g. due psychological disorders, dementia, etc.
Other
- Severe diarrhoea requiring medical attention
- Use of IN independently of the study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Who the study is looking for
- Patient undergoing open cystectomy (for all reasons)
- Age ≥18 years
- Ability and willingness to provide informed consent documented by signature
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| University Hospital of Geneva Coordinator of this site? Confirm its status | Geneva | Switzerland | Recruiting |
| Centre Hospitalier Universitaire Vaudois (CHUV) Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
| Hospital of Riviera-Chablais Coordinator of this site? Confirm its status | Rennaz | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.