Clinical trial · Interventional
Effect of Preoperative Immunonutrition in Upper Digestive Tract
Multicenter Randomized Clinical Trial of the Effect of Preoperative Immunonutrition Versus Standard Enteral Nutrition in Elective Oncological Surgery of the Upper Digestive Tract
- 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)
Randomized, double-blind, multicenter clinical trial that will evaluate the effects of immuno-nutrition in the preoperative period in patients with cancer of the upper digestive tract (esophagus, stomach, and pancreas). The aim is to compare the specific effect of the immunonutrients respect to an equivalent formula in caloric-protein value but without immunonutrients, in the surgical evolution of the cancer patient.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Immunonutrition | — | UNRESOLVED | — |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Surgery--Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunonutrition | Dietary Supplement | — | UNRESOLVED |
| Standard | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Immunonutrition
- description
- Oral nutritional supplement: hypercaloric and hyperproteic with immunonutrients: Arginine, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine
- interventionNames
- Dietary Supplement: Immunonutrition
- type
- PLACEBO_COMPARATOR
- label
- Standard
- description
- Oral nutritional supplement: hypercaloric and hyperproteic without immunonutrients
- interventionNames
- Dietary Supplement: Standard
Primary outcomes (2)
- measure
- Infectious complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of cancer of esophagus, stomach and / or pancreas, at any stage, proposed for surgery * Signing informed consent Exclusion Criteria: * Pregnant or breastfeeding * Advanced renal insufficiency prior to dialysis (GFR \<25 ml / min) * Allergy or intolerance to any of the components of the dietary supplement (including fish allergy) * Patients with contraindications for enteral nutrition
References
Publications (1)
- DERIVEDVillar-Taibo R, Vidal-Casariego A, Santamaria-Nieto A, Canton-Blanco A, Crujeiras AB, Lugo Rodriguez G, Rodriguez-Carnero G, Pita Gutierrez F, Fernandez Pombo A, Diaz-Lopez E, Roman Eyo A, Rodriguez Lavandeira U, Pena-Dubra A, Martinez-Olmos MA. Efficacy of a new immunonutrition formula with extra virgin olive oil in the reduction of complications in surgeries of upper digestive tract tumors. Front Nutr. 2024 May 28;11:1384145. doi: 10.3389/fnut.2024.1384145. eCollection 2024. PMID 38863591