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

Primary Purpose

Bladder Cancer, Interstitial Cystitis, Painful Bladder Syndrome

Status
Recruiting
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Immunonutrition
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bladder Cancer focused on measuring Cystectomy, Immunonutrition, Complication, Malnutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois, CHUVRecruiting
  • University Hospital of Bern
  • Hospital of Riviera-Chablais

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immunonutrition

No immunonutrition (control)

Arm Description

Seven days of preoperative oral supplementation with an immune-enhanced oral nutrition

Standard of care

Outcomes

Primary Outcome Measures

Infectious complication after cystectomy
Determination of infectious complications rate at 30 days after surgery (pneumonia, urinary tract infection, surgical site infection, sepsis, shock).

Secondary Outcome Measures

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).
Mortality rate
Determination of the mortality rate at 30 and 90 days after surgery
Complication-free survival rate
Determination of the post-operative complication-free survival
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.

Full Information

First Posted
January 16, 2023
Last Updated
September 1, 2023
Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
Insel Gruppe AG, University Hospital Bern, Hôpital Riviera-Chablais, Vaud-Valais
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1. Study Identification

Unique Protocol Identification Number
NCT05726786
Brief Title
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
Acronym
INCyst
Official Title
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
Collaborators
Insel Gruppe AG, University Hospital Bern, Hôpital Riviera-Chablais, Vaud-Valais

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Interstitial Cystitis, Painful Bladder Syndrome, Neurogenic Bladder, Hemorrhagic Cystitis, Endometriosis, Bladder Disease
Keywords
Cystectomy, Immunonutrition, Complication, Malnutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, prospective, controlled, pragmatic, parallel-group comparative study with block randomization stratified by centers
Masking
None (Open Label)
Allocation
Randomized
Enrollment
232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immunonutrition
Arm Type
Experimental
Arm Description
Seven days of preoperative oral supplementation with an immune-enhanced oral nutrition
Arm Title
No immunonutrition (control)
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Drug
Intervention Name(s)
Immunonutrition
Intervention Description
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
Primary Outcome Measure Information:
Title
Infectious complication after cystectomy
Description
Determination of infectious complications rate at 30 days after surgery (pneumonia, urinary tract infection, surgical site infection, sepsis, shock).
Time Frame
30-days afetr surgery
Secondary Outcome Measure Information:
Title
Comprehensive Complication Index (CCI)
Description
Determination of the Comprehensive Complication Index (CCI) at 30 and 90 days after surgery. The range is between 0 (no complication) to 100 (death).
Time Frame
30 and 90 days after surgery
Title
Mortality rate
Description
Determination of the mortality rate at 30 and 90 days after surgery
Time Frame
30 and 90 days after surgery
Title
Complication-free survival rate
Description
Determination of the post-operative complication-free survival
Time Frame
90-days after surgery
Title
Treatment compliance rate
Description
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.
Time Frame
Between Day -30 and Day -10 and at preoperative admission after intake of the allocated nutrition (Day -1)
Other Pre-specified Outcome Measures:
Title
Cancer-specific survival rate
Description
Long term overall and cancer-specific survival for bladder cancer patients
Time Frame
Postoperative time
Title
Quality of life assessment
Description
Assessment of the quality of life after surgery through a questionnaire (EORTC QLQ-C30)
Time Frame
30 and 90 days after surgery
Title
Identification of biomarkers predictive of postoperative complications
Description
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
Time Frame
Before and after immunonutrition treatement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilaria Lucca, MD
Phone
+41213142981
Email
ilaria.lucca@chuv.ch
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois, CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilaria Lucca, MD
Email
ilaria.lucca@chuv.ch
First Name & Middle Initial & Last Name & Degree
François Crettenand, MD
Email
francois.crettenand@chuv.ch
Facility Name
University Hospital of Bern
City
Bern
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard Kiss, MD
Email
bernhard.kiss@insel.ch
Facility Name
Hospital of Riviera-Chablais
City
Rennaz
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Tawadros, PhD
Email
thomas.tawadros@rivierachablais.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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