Pre-operative Immuno-Nutrition in Radical Cystectomy (INu-RC)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Bladder Cancer

Treatments: Dietary Supplement: Standard Oral Nutritional Supplement; Dietary Supplement: Immunonutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT06355518

INu-RC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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260 participants in 2 patient groups

Preoperative Immunonutrition

Experimental group

Description:

Preoperative administration of a high-calorie, high-protein liquid oral nutritional supplement containing immunonutrients \[Impact® Oral (237 mL per serving); Nestlé Health Science - Creully Sur Seulles - France\]. Two units of Impact® Oral per day will be administered for 7 days before surgery.

Treatment:

Dietary Supplement: Immunonutrition

Preoperative Standard Oral Nutritional Supplement

Active Comparator group

Description:

Preoperative administration of a standard high-calorie-high-protein liquid oral nutritional supplement \[Meritene® Protein Drink (200 mL per serving); Nestlé Health Science - Creully Sur Seulles - France\]. Two units of Meritene® Protein Drink per day will be administered for 7 days before surgery.

Treatment:

Dietary Supplement: Standard Oral Nutritional Supplement