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AzTrials

Bladder CancerINu-RCNCT06355518

Pre-operative Immuno-Nutrition in Radical Cystectomy

A study testing Immunonutrition and Standard Oral Nutritional Supplement in people with Bladder Cancer, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Immunonutrition and Standard Oral Nutritional Supplement
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
2 sitesItaly
Study dates
Apr 2024to Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Valentina Da Prat, MD contact

+390382501615

v.daprat@smatteo.pv.it

Riccardo Caccialanza, MD contact

+390382501615

r.caccialanza@smatteo.pv.it

Italy2 sites

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    Bettiga Arianna, bettiga.arianna@hsr.it

    Marco Moschini, MD

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Ferrari Alessandra, PharmD, +390382503689, alessandra.ferrari@smatteo.pv.it

    Valentina Da Prat, MD

Other trials in Italy

About this study

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

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.

Read the 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
Being tested
Immunonutrition, Standard Oral Nutritional Supplement
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImmunonutritionDietary supplement

    Also called Impact® Oral

    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 SupplementDietary supplement

    Also called Meritene® Drink

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

Study groups in NCT06355518
Study groupRoleWhat they receive
Preoperative ImmunonutritionExperimentalPreoperative 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.
Receives: Dietary Supplement: Immunonutrition
Preoperative Standard Oral Nutritional SupplementActive comparatorPreoperative 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.
Receives: Dietary Supplement: Standard Oral Nutritional Supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 30 days after surgery

Secondary outcomes (15)

  1. 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)

    Measured: 30 days after surgery

  2. 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)

    Measured: 90 days after surgery

  3. 30-day and 90-day infectious complications

    Percentage of patients developing at least one infectious complication (as detailed in the study protocol)

    Measured: 30 and 90 days after surgery

  4. 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)

    Measured: 30 and 90 days after surgery

  5. Time to recovery of bowel function

    Time from surgery to first flatus counting the day of surgery as day 0

    Measured: Immediately after surgery

  6. Time to postoperative mobilization

    Time from surgery to first walk counting the day of surgery as day 0

    Measured: Immediately after surgery

  7. Muscular strength modifications

    Difference in hand-grip strength (mean of three consecutive measurements from dominant hand) and in the sit-and-stand test

    Measured: Up hospital discharge, assessed up to 90 days

  8. Weight modifications

    Difference in body weight

    Measured: From preadmission visit to 90-day follow-up visit

  9. Biochemical nutritional indexes modifications

    Biochemical nutritional indexes

    Measured: Up to hospital discharge, assessed up to 90 days

  10. Need of blood transfusions

    Percentage of patients undergoing blood transfusions (red blood cells, plasma, and/or platelets)

    Measured: Immediately after surgery

  11. Length of stay

    Time from hospital admission to discharge at home or to another facility

    Measured: Immediately after surgery

  12. Readmission rate

    Incidence of unplanned re-hospitalization due to all causes

    Measured: 30 and 90 days after surgery

  13. 30-day and 90-day mortality

    Death rate due to all causes

    Measured: 30 and 90 days after surgery

  14. Compliance

    Percentage of patients consuming ≥80% of the prescribed supplement

    Measured: 7 days before surgery

  15. Tolerability (gastrointestinal symptoms related to nutritional supplement)

    Percentage of patients experiencing at least one moderate-severe adverse gastrointestinal effects

    Measured: 7 days before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2024
  2. Study startApr 2024 (estimated)
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06355518
Sponsor's protocol ID
INu-RC
Acronym
INu-RC
Status last verified
Apr 2024
First submitted
19 Mar 2024
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37509408

Questions about this trial

What is this clinical trial studying?

A study testing Immunonutrition and Standard Oral Nutritional Supplement in people with Bladder Cancer, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Valentina Da Prat, MD (+390382501615, v.daprat@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day complications (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06355518, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.

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