Clinical trial NCT06355518: Pre-operative Immuno-Nutrition in Radical Cystectomy
Official title: Pre-operative Immuno-nutrition in Patients Undergoing Radical Cystectomy for Bladder Cancer: a Multicentre, Randomised, Open-label, Parallel Group Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: IRCCS Ospedale San Raffaele
First posted: 2024-04-09
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of preoperative oral immunonutrition on postoperative complications in patients undergoing radical cystectomy for bladder cancer. Patients receiving preoperative immunonutrition will be compared to controls receiving a standard high-calorie, high-protein oral nutritional supplement.

Detailed description: Radical cystectomy with pelvic lymph node dissection and urinary reconstruction is a major surgical procedure performed for bladder cancer. The literature reports an incidence of 50-88% and 30-42% for any grade complications (Clavier-Dindo grade I-IV) and severe complications (Clavier-Dindo grade ≥III), respectively. Nutritional status prior to radical cystectomy has been shown to be a strong predictor of 90-day mortality. The term "immunonutrition" refers to the oral or enteral administration of specific substrates such as omega-3 fatty acids, arginine, and nucleotides. These substrates have been shown to upregulate the host immune response, modulate inflammatory responses and improve protein synthesis after surgery, with a favorable impact on postoperative infection rates and length of hospital stay in major abdominal surgery. Data on patients undergoing radical cystectomy are scarce, mainly due to the small sample size of the studies. However, the available evidence suggests a potential beneficial effect of this nutritional intervention in patients undergoing radical cystectomy. Several aspects remain largely unclear, including the dosage and timing of immunonutrition and the impact of preoperative malnutrition risk on the efficacy of immunonutrition. This study will evaluate the effect of 7 days of preoperative immunonutrition on postoperative complications compared to patients receiving standard high-calorie, high-protein oral nutritional supplements.

Eligibility criteria: Inclusion Criteria:

* Surgical indication to radical cystectomy with diagnosis of muscle invasive bladder cancer (any N, any M), BCG (Bacillus Calmette-Guerin)-unresponsive non-muscle invasive bladder cancer or extensive non-muscle invasive bladder cancer that cannot be treated with endoscopic surgery alone;
* Willingness to participate by signing written informed consent.

Exclusion Criteria:

* Age \< 18 years;
* Pregnant or lactating women;
* Participation in another study with nutritional supplements within the 30 days preceding and during the present study
* Known hypersensitivity or allergy to components of immunonutrition or standard high-calorie high-protein oral nutritional supplement;
* Need for artificial nutrition support due to totally compromised spontaneous food intake;
* Diarrhoea with suspected malabsorption syndrome;
* Inability to consume oral supplements as a consequence of pre-existing disease (e.g. dysphagia) or other factors (e.g. language barrier, psychological disorders, absence of a home caregiver in dependent or elderly patients);
* Kidney failure with need for renal replacement therapy;
* Type 1 diabetes mellitus;
* Type 2 diabetes mellitus requiring insulin therapy and/or inadequate glycaemic control (glycosylated haemoglobin ≥7% and/or fasting plasma glucose ≥150 mg/dL);
* Inability to give an informed consent.

Primary outcomes:
measure: 30-day complications
timeFrame: 30 days after surgery
Secondary outcomes:
measure: 30-day severe complications
timeFrame: 30 days after surgery
measure: 90-day severe complications
timeFrame: 90 days after surgery
measure: 30-day and 90-day infectious complications
timeFrame: 30 and 90 days after surgery
measure: 30-day and 90-day occurrence of other medical conditions
timeFrame: 30 and 90 days after surgery
measure: Time to recovery of bowel function
timeFrame: Immediately after surgery
measure: Time to postoperative mobilization
timeFrame: Immediately after surgery
measure: Muscular strength modifications
timeFrame: Up hospital discharge, assessed up to 90 days
measure: Weight modifications
timeFrame: From preadmission visit to 90-day follow-up visit
measure: Biochemical nutritional indexes modifications
timeFrame: Up to hospital discharge, assessed up to 90 days
measure: Need of blood transfusions
timeFrame: Immediately after surgery
measure: Length of stay
timeFrame: Immediately after surgery
measure: Readmission rate
timeFrame: 30 and 90 days after surgery
measure: 30-day and 90-day mortality
timeFrame: 30 and 90 days after surgery
measure: Compliance
timeFrame: 7 days before surgery
measure: Tolerability (gastrointestinal symptoms related to nutritional supplement)
timeFrame: 7 days before surgery
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
References:
citation: Casirati A, Da Prat V, Bettiga A, Aretano L, Trevisani F, Cereda E, Briganti A, Colombo E, Preziati G, De Simeis F, Salonia A, Montorsi F, Caccialanza R, Naspro R. Immunonutrition in Radical Cystectomy: State of the Art and Perspectives. Cancers (Basel). 2023 Jul 24;15(14):3747. doi: 10.3390/cancers15143747.