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

December 2, 2025 updated by: Ilaria Lucca, Centre Hospitalier Universitaire Vaudois

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Despite standardized surgical technique and the development of new perioperative care protocols, cystectomy morbidity remains a serious challenge for urologists. Most common postoperative complications, such as infections, often lead to longer length of stay and worse survival. Malnutrition has been identified as an independent and modifiable risk factor for both mortality and morbidity. Immunonutrition (IN), containing arginine, ribonucleic acid and omega-3 polyunsaturated fatty acids, aims to improve the nutritional status, immunological function and clinical outcome of surgical patients. Meta-analyses have demonstrated that preoperative IN reduces complications and length of hospital stay after major bowel surgery. Evidence-based data on preoperative oral IN support for cystectomy patients are lacking, which does not allow this treatment to be widely accepted, recommended, or reimbursed by health insurances in most European countries. Uncertainties also remain about the exact mechanism by which IN modulates the host immune response.

Complication rates after cystectomy range from 40-75%. Malnutrition has been identified as an independent and modifiable risk factor for both mortality and morbidity. To date, and in the last 20 years, no single intervention has allowed for a significant reduction in morbidity after cystectomy, which remains one of the highest in surgery. The present adequately powered multicenter RCT has the potential of changing current practice by recommending preoperative IN before cystectomy in case of positive results. If the present RCT demonstrates a benefit in administrating IN prior to cystectomy, urological guidelines will be modified accordingly to this new evidence. IN will then be recommended before cystectomy for the patient's benefit. The investigators truly believe that the proposed study is of high clinical importance with potential impact on perioperative urology guidelines.

Study Type

Interventional

Enrollment (Estimated)

232

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immunonutrition
Seven days of preoperative oral supplementation with an immune-enhanced oral nutrition
Drug: Immunonutrition

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
No Intervention: No immunonutrition (control)
Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infectious complication after cystectomy
Time Frame: 30-days afetr surgery
Determination of infectious complications rate at 30 days after surgery (pneumonia, urinary tract infection, surgical site infection, sepsis, shock).
30-days afetr surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehensive Complication Index (CCI)
Time Frame: 30 and 90 days after surgery
Determination of the Comprehensive Complication Index (CCI) at 30 and 90 days after surgery. The range is between 0 (no complication) to 100 (death).
30 and 90 days after surgery
Mortality rate
Time Frame: 30 and 90 days after surgery
Determination of the mortality rate at 30 and 90 days after surgery
30 and 90 days after surgery
Complication-free survival rate
Time Frame: 90-days after surgery
Determination of the post-operative complication-free survival
90-days after surgery
Treatment compliance rate
Time Frame: Between Day -30 and Day -10 and at preoperative admission after intake of the allocated nutrition (Day -1)
Serum arginine levels will be assessed at enrolment (between Day -30 and Day -10) and at preoperative admission after intake of the allocated nutrition (Day -1) in all patients treated at Lausanne, CHUV.
Between Day -30 and Day -10 and at preoperative admission after intake of the allocated nutrition (Day -1)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer-specific survival rate
Time Frame: Postoperative time
Long term overall and cancer-specific survival for bladder cancer patients
Postoperative time
Quality of life assessment
Time Frame: 30 and 90 days after surgery
Assessment of the quality of life after surgery through a questionnaire (EORTC QLQ-C30)
30 and 90 days after surgery
Identification of biomarkers predictive of postoperative complications
Time Frame: Before and after immunonutrition treatement
Identification of biomarkers predictive of postoperative complications studying the patient's immune and microbiome signature: analysis of immune cells in the blood, analysis of the polyfunctionality of blood T cells, analysis of immune-related proteins in the urine and serum, microbiota analysis, expression of Argininosuccinate synthetase 1
Before and after immunonutrition treatement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Collaborators

University Hospital, Geneva
Hôpital Riviera-Chablais, Vaud-Valais
Insel Gruppe AG, University Hospital Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCyst

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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