NCT05726786 The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
| NCT ID | NCT05726786 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Hospitalier Universitaire Vaudois |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 232 participants |
| Start Date | 2023-04-10 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 232 participants in total. It began in 2023-04-10 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05726786 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05726786 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 232 participants.
Is NCT05726786 currently recruiting?
Yes, NCT05726786 is actively recruiting participants. Contact the research team at ilaria.lucca@chuv.ch for enrollment information.
Where is the NCT05726786 trial being conducted?
This trial is being conducted at Lausanne, Switzerland, Bern, Switzerland, Geneva, Switzerland, Rennaz, Switzerland.
Who is sponsoring the NCT05726786 clinical trial?
NCT05726786 is sponsored by Centre Hospitalier Universitaire Vaudois. The trial plans to enroll 232 participants.
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