Pre-operative Immuno-Nutrition in Radical Cystectomy

NCT ID: NCT06355518

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2026-09-30

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Preoperative Immunonutrition

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.

Group Type: EXPERIMENTAL

Immunonutrition

Intervention Type: 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.

Preoperative Standard Oral Nutritional Supplement

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.

Group Type: ACTIVE_COMPARATOR

Standard Oral Nutritional Supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Immunonutrition

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.

Intervention Type: DIETARY_SUPPLEMENT

Standard Oral Nutritional Supplement

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Impact® Oral; Meritene® Drink

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Ospedale San Raffaele

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Ospedale San Raffaele

Milan, , Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Countries

Italy

Central Contacts

Valentina Da Prat, MD

Role: CONTACT

v.daprat@smatteo.pv.it

+390382501615

Riccardo Caccialanza, MD

Role: CONTACT

r.caccialanza@smatteo.pv.it

+390382501615

Facility Contacts

Bettiga Arianna

Role: primary

bettiga.arianna@hsr.it

Ferrari Alessandra, PharmD

Role: primary

alessandra.ferrari@smatteo.pv.it

+390382503689

References

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.

Reference Type: BACKGROUND

PMID: 37509408 (View on PubMed)

Other Identifiers

INu-RC

Identifier Type: -

Identifier Source: org_study_id