Effect of Preoperative Immunonutrition in Upper Digestive Tract

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-10

Study Completion Date

2021-12-31

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.

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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).

Conditions

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Immunonutrition Gastric Cancer Esophageal Cancer Pancreas Cancer Surgery--Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Immunonutrition

Oral nutritional supplement: hypercaloric and hyperproteic with immunonutrients: Arginine, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine

Group Type EXPERIMENTAL

Immunonutrition

Intervention Type DIETARY_SUPPLEMENT

It is a hypercaloric and hyperproteic dietary supplement formulated with immunonutrients: Arginin, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine

Standard

Oral nutritional supplement: hypercaloric and hyperproteic without immunonutrients

Group Type PLACEBO_COMPARATOR

Standard

Intervention Type DIETARY_SUPPLEMENT

It is a hypercaloric and hyperproteic dietary supplement formulated without immunonutrients

Interventions

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Immunonutrition

It is a hypercaloric and hyperproteic dietary supplement formulated with immunonutrients: Arginin, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine

Intervention Type DIETARY_SUPPLEMENT

Standard

It is a hypercaloric and hyperproteic dietary supplement formulated without immunonutrients

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Bi1 procare

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No