The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
INCyst
1 other identifier
interventional
232
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2023
Typical duration for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2023
CompletedFirst Posted
Study publicly available on registry
February 14, 2023
CompletedStudy Start
First participant enrolled
April 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
December 9, 2025
December 1, 2025
3.3 years
January 16, 2023
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infectious complication after cystectomy
Determination of infectious complications rate at 30 days after surgery (pneumonia, urinary tract infection, surgical site infection, sepsis, shock).
30-days afetr surgery
Secondary Outcomes (4)
Comprehensive Complication Index (CCI)
30 and 90 days after surgery
Mortality rate
30 and 90 days after surgery
Complication-free survival rate
90-days after surgery
Treatment compliance rate
Between Day -30 and Day -10 and at preoperative admission after intake of the allocated nutrition (Day -1)
Other Outcomes (3)
Cancer-specific survival rate
Postoperative time
Quality of life assessment
30 and 90 days after surgery
Identification of biomarkers predictive of postoperative complications
Before and after immunonutrition treatement
Study Arms (2)
Immunonutrition
EXPERIMENTALSeven days of preoperative oral supplementation with an immune-enhanced oral nutrition
No immunonutrition (control)
NO INTERVENTIONStandard of care
Interventions
Immunonutrition: Oral Impact®, Nestlé Health Science, Switzerland. IN will be administered as per manufacturer suggestion, i.e. three times a day during 7 days preoperatively. Oral Impact® is a powdered oral feed that provides 309 kcal/bag
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire Vaudoislead
- Insel Gruppe AG, University Hospital Berncollaborator
- Hôpital Riviera-Chablais, Vaud-Valaiscollaborator
- University Hospital, Genevacollaborator
Study Sites (4)
Centre Hospitalier Universitaire Vaudois, CHUV
Lausanne, Canton of Vaud, 1011, Switzerland
University Hospital of Bern
Bern, Switzerland
University Hospital of Geneva
Geneva, Switzerland
Hospital of Riviera-Chablais
Rennaz, Switzerland
Related Publications (1)
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.
PMID: 39415282DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Principal Investigator
Study Record Dates
First Submitted
January 16, 2023
First Posted
February 14, 2023
Study Start
April 10, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
December 9, 2025
Record last verified: 2025-12