Esophageal Cancer, Gastric Cancer, Immunonutrition, Pancreas Cancer, Surgery--Complications
Conditions
Keywords
immunonutrition, surgery, postoperative complications, length of hospital stay, nutritional status
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).
Interventions
DIETARY_SUPPLEMENTImmunonutrition
It is a hypercaloric and hyperproteic dietary supplement formulated with immunonutrients: Arginin, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine
DIETARY_SUPPLEMENTStandard
It is a hypercaloric and hyperproteic dietary supplement formulated without immunonutrients
Sponsors
Complexo Hospitalario Universitario de A Coruña
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infectious complications | Up to 30 days post-operative |
| Surgical fistulas | Up to 30 days post-operative |
Secondary
| Measure | 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 |
Countries
Spain
Contacts
Primary ContactAlfonso Vidal-Casariego, PhD, MD
Outcome results
None listed