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Trial Title:
Pre-operative Immuno-Nutrition in Radical Cystectomy
NCT ID:
NCT06355518
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Immunonutrition
Description:
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.
Arm group label:
Preoperative Immunonutrition
Other name:
Impact® Oral
Intervention type:
Dietary Supplement
Intervention name:
Standard Oral Nutritional Supplement
Description:
This formula provides 38 grams of protein and 500 kcal/day with the proposed therapeutic
volume.
Arm group label:
Preoperative Standard Oral Nutritional Supplement
Other name:
Meritene® Drink
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS Ospedale San Raffaele
Address:
City:
Milan
Zip:
20132
Country:
Italy
Contact:
Last name:
Bettiga Arianna
Email:
bettiga.arianna@hsr.it
Investigator:
Last name:
Marco Moschini, MD
Email:
Principal Investigator
Facility:
Name:
Fondazione IRCCS Policlinico San Matteo
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Contact:
Last name:
Ferrari Alessandra, PharmD
Phone:
+390382503689
Email:
alessandra.ferrari@smatteo.pv.it
Investigator:
Last name:
Valentina Da Prat, MD
Email:
Principal Investigator
Start date:
April 2024
Completion date:
September 2026
Lead sponsor:
Agency:
Fondazione IRCCS Policlinico San Matteo di Pavia
Agency class:
Other
Collaborator:
Agency:
IRCCS Ospedale San Raffaele
Agency class:
Other
Source:
Fondazione IRCCS Policlinico San Matteo di Pavia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06355518
