Trial Title:
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
NCT ID:
NCT05726786
Condition:
Bladder Cancer
Interstitial Cystitis
Painful Bladder Syndrome
Neurogenic Bladder
Hemorrhagic Cystitis
Endometriosis
Bladder Disease
Conditions: Official terms:
Urinary Bladder, Neurogenic
Endometriosis
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Cystitis, Hemorrhagic
Conditions: Keywords:
Cystectomy
Immunonutrition
Complication
Malnutrition
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Multicenter, prospective, controlled, pragmatic, parallel-group comparative study with
block randomization stratified by centers
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Immunonutrition
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
Arm group label:
Immunonutrition
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.
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Universitaire Vaudois, CHUV
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Ilaria Lucca, MD
Email:
ilaria.lucca@chuv.ch
Contact backup:
Last name:
François Crettenand, MD
Email:
francois.crettenand@chuv.ch
Facility:
Name:
University Hospital of Bern
Address:
City:
Bern
Country:
Switzerland
Status:
Not yet recruiting
Contact:
Last name:
Bernhard Kiss, MD
Email:
bernhard.kiss@insel.ch
Facility:
Name:
Hospital of Riviera-Chablais
Address:
City:
Rennaz
Country:
Switzerland
Status:
Not yet recruiting
Contact:
Last name:
Thomas Tawadros, PhD
Email:
thomas.tawadros@rivierachablais.ch
Start date:
April 10, 2023
Completion date:
October 2026
Lead sponsor:
Agency:
Centre Hospitalier Universitaire Vaudois
Agency class:
Other
Collaborator:
Agency:
Insel Gruppe AG, University Hospital Bern
Agency class:
Other
Collaborator:
Agency:
Hôpital Riviera-Chablais, Vaud-Valais
Agency class:
Other
Source:
Centre Hospitalier Universitaire Vaudois
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05726786
