Clinical trial NCT04027088: Effect of Preoperative Immunonutrition in Upper Digestive Tract
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immunonutrition
Gastric Cancer
Esophageal Cancer
Pancreas Cancer
Surgery--Complications
Keywords: immunonutrition
surgery
postoperative complications
length of hospital stay
nutritional status
Lead sponsor: Complexo Hospitalario Universitario de A Coruña
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Infectious complications
timeFrame: Up to 30 days post-operative
measure: Surgical fistulas
timeFrame: Up to 30 days post-operative
Secondary outcomes:
measure: Mortality
timeFrame: Up to 30 days post-operative
measure: Length of hospital stay
timeFrame: Up to 30 days post-operative
measure: Weight loss
timeFrame: 10 days Pre-operative
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Miguel A. Martínez Olmos
state: A Coruña
city: A Coruña
country: Spain
facility: Alfonso Vidal-Casariego
state: La Coruna
Study officials:
affiliation: Complexo Hospitalario Universitario de Santiago
name: Miguel Á Martínez-Olmos, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complexo Hospitalario Universitario de A Coruña
name: Alfonso Vidal-Casariego, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: