Pre-operative Immuno-Nutrition in Radical Cystectomy

NCT06355518 | Not Yet Recruiting

• 1 other identifier: INu-RC
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 30-day complications

  Percentage of patients developing at least one post-operative complication (as detailed in the study protocol: infectious, urinary, gastrointestinal, and wound-related complications)

  30 days after surgery

Secondary Outcomes (15)

• 30-day severe complications

  30 days after surgery

• 90-day severe complications

  90 days after surgery

• 30-day and 90-day infectious complications

  30 and 90 days after surgery

• 30-day and 90-day occurrence of other medical conditions

  30 and 90 days after surgery

• Time to recovery of bowel function

  Immediately after surgery

Study Arms (2)

Preoperative Immunonutrition

EXPERIMENTAL

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.

Dietary Supplement: Immunonutrition

Preoperative Standard Oral Nutritional Supplement

ACTIVE COMPARATOR

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.

Dietary Supplement: Standard Oral Nutritional Supplement

Interventions

Immunonutrition DIETARY_SUPPLEMENT

This formula is enriched in arginine, nucleotides (RNA) and omega-3 fatty acids and provides, with the proposed therapeutic volume (2 units per day), 36 grams of protein and 682 kcal/day.

Also known as: Impact® Oral

Preoperative Immunonutrition

Standard Oral Nutritional Supplement DIETARY_SUPPLEMENT

This formula provides 38 grams of protein and 500 kcal/day with the proposed therapeutic volume.

Also known as: Meritene® Drink

Preoperative Standard Oral Nutritional Supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• IRCCS Ospedale San Raffaele: collaborator

Study Sites (2)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (1)

• 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.

  PMID: 37509408 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Valentina Da Prat, MD

CONTACT

+390382501615; v.daprat@smatteo.pv.it

Riccardo Caccialanza, MD

CONTACT

+390382501615; r.caccialanza@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 9, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

IT (2)