Clinical trial · Interventional
Pre-operative Immuno-Nutrition in Radical Cystectomy
Pre-operative Immuno-nutrition in Patients Undergoing Radical Cystectomy for Bladder Cancer: a Multicentre, Randomised, Open-label, Parallel Group Study
NCT06355518CI-TRIAL-00075851INu-RCnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunonutrition | Dietary Supplement | — | UNRESOLVED |
| Standard Oral Nutritional Supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Preoperative Immunonutrition
- 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.
- interventionNames
- Dietary Supplement: Immunonutrition
- type
- ACTIVE_COMPARATOR
- label
- Preoperative Standard Oral Nutritional Supplement
- 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.
- interventionNames
- Dietary Supplement: Standard Oral Nutritional Supplement
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDCasirati 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. PMID 37509408