Bladder CancerPhase 3INCystNCT05726786
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
A Phase 3 study testing Immunonutrition in people with Bladder Cancer and Interstitial Cystitis, run by Centre Hospitalier Universitaire Vaudois at 4 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Interstitial Cystitis, Painful Bladder Syndrome
- What is being tested?
- Immunonutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 10 Apr 2023to Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing open cystectomy (for all reasons)
- Age ≥18 years
- Ability and willingness to provide informed consent documented by signature
Who cannot join
- 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.
Show all 11Show fewer
- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland4 sites, 4 recruiting
- Recruiting
University Hospital of Bern
Bern
Beat Roth, MD, beat.roth@insel.ch
- Recruiting
University Hospital of Geneva
Geneva
Philippe Sebe, Prof, +41223723311, philippe.sebe@hug.ch
- Recruiting
Centre Hospitalier Universitaire Vaudois, CHUV
Lausanne, Canton of Vaud, 1011
Ilaria Lucca, MD, ilaria.lucca@chuv.ch
François Crettenand, MD, francois.crettenand@chuv.ch
- Recruiting
Hospital of Riviera-Chablais
Rennaz
Thomas Tawadros, PhD, thomas.tawadros@rivierachablais.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- Bladder Cancer, Interstitial Cystitis, Painful Bladder Syndrome, Neurogenic Bladder, Hemorrhagic Cystitis, Endometriosis
- Being tested
- Immunonutrition
- Keywords
- Cystectomy, Immunonutrition, Complication, Malnutrition
- Medical subject headings
- Urinary Bladder Neoplasms, Cystitis, Interstitial, Urinary Bladder, Neurogenic, Cystitis, Hemorrhagic, Endometriosis, Urinary Bladder Diseases, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunonutritionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Immunonutrition | Experimental | Seven days of preoperative oral supplementation with an immune-enhanced oral nutrition Receives: Drug: Immunonutrition |
| No immunonutrition (control) | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious complication after cystectomy
Determination of infectious complications rate at 30 days after surgery (pneumonia, urinary tract infection, surgical site infection, sepsis, shock).
Measured: 30-days afetr surgery
Secondary outcomes (4)
Comprehensive Complication Index (CCI)
Determination of the Comprehensive Complication Index (CCI) at 30 and 90 days after surgery. The range is between 0 (no complication) to 100 (death).
Measured: 30 and 90 days after surgery
Mortality rate
Determination of the mortality rate at 30 and 90 days after surgery
Measured: 30 and 90 days after surgery
Complication-free survival rate
Determination of the post-operative complication-free survival
Measured: 90-days after surgery
Treatment compliance rate
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.
Measured: Between Day -30 and Day -10 and at preoperative admission after intake of the allocated nutrition (Day -1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start10 Apr 2023
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, prospective, controlled, pragmatic, parallel-group comparative study with block randomization stratified by centers
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Hôpital Riviera-Chablais, Vaud-Valais, University Hospital, Geneva
- Responsible party
- Principal investigator, Ilaria Lucca, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726786
- Sponsor's protocol ID
- INCyst
- Acronym
- INCyst
- Status last verified
- Dec 2025
- First submitted
- 16 Jan 2023
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39415282
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)
- ClinicalTrials.gov ID
- NCT05726786
- Acronym / sponsor ID
- INCyst / INCyst
- Conditions
- Bladder Cancer, Interstitial Cystitis, Painful Bladder Syndrome, Neurogenic Bladder, Hemorrhagic Cystitis, Endometriosis
- Keywords
- Cystectomy, Immunonutrition, Complication, Malnutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Hôpital Riviera-Chablais, Vaud-Valais, University Hospital, Geneva
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, prospective, controlled, pragmatic, parallel-group comparative study with block randomization stratified by centers
| Arm | Type | Receives |
|---|---|---|
| Immunonutrition | Experimental | Drug: ImmunonutritionSeven days of preoperative oral supplementation with an immune-enhanced oral nutrition |
| No immunonutrition (control) | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient undergoing open cystectomy (for all reasons)
- Age ≥18 years
- Ability and willingness to provide informed consent documented by signature
Key exclusion criteria (11 listed)
- 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, ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunonutritionImmunonutrition: 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 | Drug | Immunonutrition |
Primary outcome
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).
4 secondary outcomes
Comprehensive Complication Index (CCI)
Time frame: 30 and 90 days after surgery
Mortality rate
Time frame: 30 and 90 days after surgery
Complication-free survival rate
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Derived from this study: PubMed 39415282Derre 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.
- Individual participant dataSharing planned: Undecided
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immunonutrition in people with Bladder Cancer and Interstitial Cystitis, run by Centre Hospitalier Universitaire Vaudois at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilaria Lucca, MD (+41213142980, ilaria.lucca@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infectious complication after cystectomy (time frame: 30-days afetr surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05726786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.