Effect of Preoperative Immunonutrition in Upper Digestive Tract

Study Overview
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Brief Summary
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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.

Detailed Description
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Background: Perioperative nutritional status is a key factor in the evolution, as well as, postoperative morbidity and mortality of cancer patients. Particularly, digestive neoplasms have a high risk of malnutrition and this is related to a higher rate of surgery complications and mortality in the postoperative period. The immunonutrition seems to modulate the immune system and the inflammatory response in patients operated on for digestive neoplasia. However, the results to date are controversial. Aim: To compare the effect of an immunomodulatory oral nutritional supplement (enriched in arginine, nucleotides, omega 3 fatty acids, olive oil polyphenols, L-carnitine, and antioxidants) against an equivalent in protein-energy without immunonutrients, administrated in the preoperative period, in the surgical evolution of the cancer patient with neoplasia of the upper digestive tract. Methods: It is a randomized, double-blind, multicenter clinical trial. 178 patients with neoplasms of the esophagus, stomach or pancreas, with indication of surgical treatment, will be included. The patients will be randomized into two groups (intervention group and control group) and both will receive 2 daily bricks of the assigned formula (with or without immunonutrients, respectively) 5 days prior to surgery. The main variables of the study are: appearance of infectious or noninfectious complications in the postoperative period, length of hospital stay, and mortality. These variables will be compared by group (immunonutrition vs. non immunonutrition).

Official Title
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Multicenter Randomized Clinical Trial of the Effect of Preoperative Immunonutrition Versus Standard Enteral Nutrition in Elective Oncological Surgery of the Upper Digestive Tract

Conditions
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Immunonutrition, Gastric Cancer, Esophageal Cancer, Pancreas Cancer, Surgery--Complications

Intervention / Treatment
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* Dietary Supplement: Immunonutrition
* Dietary Supplement: Standard


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunonutrition<br>Oral nutritional supplement: hypercaloric and hyperproteic with immunonutrients: Arginine, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine | Dietary Supplement: Immunonutrition<br>* It is a hypercaloric and hyperproteic dietary supplement formulated with immunonutrients: Arginin, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine<br>* Other names: Bi1 procare;|
| Placebo Comparator: Standard<br>Oral nutritional supplement: hypercaloric and hyperproteic without immunonutrients | Dietary Supplement: Standard<br>* It is a hypercaloric and hyperproteic dietary supplement formulated without immunonutrients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious complications |  | Up to 30 days post-operative | 
| Surgical fistulas |  | Up to 30 days post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Up to 30 days post-operative | 
| Length of hospital stay |  | Up to 30 days post-operative | 
| Weight loss |  | 10 days Pre-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunonutrition, surgery, postoperative complications, length of hospital stay, nutritional status