Effect of Preoperative Immunonutrition in Upper Digestive Tract

Complexo Hospitalario Universitario de A Coruña

Status: Unknown

Conditions: Esophageal Cancer; Gastric Cancer; Surgery--Complications; Pancreas Cancer; Immunonutrition

Treatments: Dietary Supplement: Standard; Dietary Supplement: Immunonutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT04027088

2018/548

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 178 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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178 participants in 2 patient groups, including a placebo group

Immunonutrition

Experimental group

Description:

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

Treatment:

Dietary Supplement: Immunonutrition

Standard

Placebo Comparator group

Description:

Oral nutritional supplement: hypercaloric and hyperproteic without immunonutrients

Treatment:

Dietary Supplement: Standard