Gastric Cancer Clinical Trial
Official title:
Multicenter Randomized Clinical Trial of the Effect of Preoperative Immunonutrition Versus Standard Enteral Nutrition in Elective Oncological Surgery of the Upper Digestive Tract
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.
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).
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