Clinical trial · Interventional
Influence of Immune Nutrition Diet on 90-Day Outcomes in Patients Undergoing Radical Cystectomy
Influence of Immune Nutrition Diet on 90-Day Outcomes in Patients Undergoing Radical Cystectomy and Bladder Substitutions: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomised double-blinded placebo-controlled phase IV trial with two parallel treatment groups receiving either immune nutrition diet (IND) or conventional diet for 2weeks peri-radical cystectomy. Patients will be stratified according to the gender, body mass index, and the type of urinary diversion (orthotopic neobladder or ileal conduit). The primary end-point is to determine, in intention to treat analysis, the influence of IND on 90-day postoperative morbidity. Secondary study end-points will be the effect of IND on infectious as well as non-infectious complications over 90 days, compliance and adverse effects of IND. Finally, an ancillary study will be performed to evaluate whether the IND costs could counterbalance, by its benefits, the health care costs.It is envisaged to finish patients' recruitment within 24 months
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Complication | — | UNRESOLVED | — |
| Infection | — | UNRESOLVED | — |
| Muscle Invasive | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
| Radical Cystectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bio-tech and omega-3 plus | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Bio-tech and omega-3 plus
- description
- Bio-tech (Biopharm pharmaceutical) powder 30 mg t.d.s. (contains multivitamins and essential amino acids) plus omega-3 plus (SEDICO pharmaceutical) capsules t.d.s (source for omega-3 fatty acids) 1 week before and 2 week after surgery
- interventionNames
- Drug: Bio-tech and omega-3 plus
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- placebo powder 30 mg t.d.s plus placebo capsules t.d.s for 1 week before and 2 week after surgery
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- The overall 90-day postoperative complication between groups measured by modified Dindo-Clavien system
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with bladder cancer eligible for radical cystectomy and urinary diversions * Willing to be randomized Exclusion Criteria: * Non-compliance and /or allergy with oral nutrition diet. * Non-organ confined disease * Associated comorbidities e.g. Gout and Rheumatoid arthritis * Weight loss more than10% (with respect to usual body weight) in the past 6 months * Hepatic dysfunction (Child-Pugh class more than B), and renal dysfunction (serum creatinine level more than3 mg/dL, hemodialysis), * Untreated infections * Immune disorders. * Chronic gastrointestinal tract disease eg.crohn's disease or previous surgery.
References
Publications (0)
Data not yet available