Pre-operative Immuno-Nutrition in Radical Cystectomy

Bladder Cancer Clinical Trial

— INu-RC  

Official title:

Pre-operative Immuno-nutrition in Patients Undergoing Radical Cystectomy for Bladder Cancer: a Multicentre, Randomised, Open-label, Parallel Group Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06355518
• Other study ID #: INu-RC
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: Fondazione IRCCS Policlinico San Matteo di Pavia
• Contact: Valentina Da Prat, MD
• Phone: +390382501615
• Email: v.daprat[@]smatteo.pv.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Dietary Supplement:
• 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.
• Standard Oral Nutritional Supplement
This formula provides 38 grams of protein and 500 kcal/day with the proposed therapeutic volume.

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione IRCCS Policlinico San Matteo di Pavia	IRCCS Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30-day severe complications	Percentage of patients developing at least one Clavien-Dindo grade =III post-operative complication (as detailed in the study protocol: infectious, urinary, gastrointestinal, and wound-related complications)	30 days after surgery
Secondary	90-day severe complications	Percentage of patients developing at least one Clavien-Dindo grade =III post-operative complication (as detailed in the study protocol: infectious, urinary, gastrointestinal, and wound-related complications)	90 days after surgery
Secondary	30-day and 90-day infectious complications	Percentage of patients developing at least one infectious complication (as detailed in the study protocol)	30 and 90 days after surgery
Secondary	30-day and 90-day occurrence of other medical conditions	Percentage of patients developing at least one other medical conditions (as detailed in the study protocol)	30 and 90 days after surgery
Secondary	Time to recovery of bowel function	Time from surgery to first flatus counting the day of surgery as day 0	Immediately after surgery
Secondary	Time to postoperative mobilization	Time from surgery to first walk counting the day of surgery as day 0	Immediately after surgery
Secondary	Muscular strength modifications	Difference in hand-grip strength (mean of three consecutive measurements from dominant hand) and in the sit-and-stand test	Up hospital discharge, assessed up to 90 days
Secondary	Weight modifications	Difference in body weight	From preadmission visit to 90-day follow-up visit
Secondary	Biochemical nutritional indexes modifications	Biochemical nutritional indexes	Up to hospital discharge, assessed up to 90 days
Secondary	Need of blood transfusions	Percentage of patients undergoing blood transfusions (red blood cells, plasma, and/or platelets)	Immediately after surgery
Secondary	Length of stay	Time from hospital admission to discharge at home or to another facility	Immediately after surgery
Secondary	Readmission rate	Incidence of unplanned re-hospitalization due to all causes	30 and 90 days after surgery
Secondary	30-day and 90-day mortality	Death rate due to all causes	30 and 90 days after surgery
Secondary	Compliance	Percentage of patients consuming =80% of the prescribed supplement	7 days before surgery
Secondary	Tolerability (gastrointestinal symptoms related to nutritional supplement)	Percentage of patients experiencing at least one moderate-severe adverse gastrointestinal effects	7 days before surgery