NCT05726786Recruiting
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
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.
Inclusion criteria
• Patient undergoing open cystectomy (for all reasons) • Age ≥18 years • Ability and willingness to provide informed consent documented by signature
Exclusion criteria
• 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)
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- Centre Hospitalier Universitaire Vaudois(Other)
- Protocol no.
- INCyst
- Conditions
- Bladder Cancer, Interstitial Cystitis, Painful Bladder Syndrome, Neurogenic Bladder, Hemorrhagic Cystitis, Endometriosis, Bladder Disease
- Interventions
- Drug
Treatments studied
- Immunonutrition
Collaborators
Insel Gruppe AG, University Hospital Bern, Hôpital Riviera-Chablais, Vaud-Valais, University Hospital, Geneva
Locations · 4
- Lausanne, SwitzerlandCentre Hospitalier Universitaire Vaudois, CHUVRecruiting at this site
- Bern, SwitzerlandUniversity Hospital of BernRecruiting at this site
- Geneva, SwitzerlandUniversity Hospital of GenevaRecruiting at this site
- Rennaz, SwitzerlandHospital of Riviera-ChablaisRecruiting at this site
In total, worldwide, all 4 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: December 9, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.