Effect of Preoperative Immunonutrition in Upper Digestive Tract

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04027088
• Other study ID #: 2018/548
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2019
• Source: Complexo Hospitalario Universitario de A Coruña
• Contact: Alfonso Vidal-Casariego, PhD, MD
• Phone: +34981176442
• Email: alfonso.vidal.casariego[@]sergas.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: December 31, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Gastric Cancer
• Immunonutrition
• Pancreas Cancer
• Pancreatic Neoplasms
• Surgery--Complications

Intervention

Dietary Supplement:
• Immunonutrition
It is a hypercaloric and hyperproteic dietary supplement formulated with immunonutrients: Arginin, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine
• Standard
It is a hypercaloric and hyperproteic dietary supplement formulated without immunonutrients

Locations

Country	Name	City	State
Spain	Alfonso Vidal-Casariego	A Coruña	La Coruna
Spain	Miguel A. Martínez Olmos	Santiago De Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Complexo Hospitalario Universitario de A Coruña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infectious complications		Up to 30 days post-operative
Primary	Surgical fistulas		Up to 30 days post-operative
Secondary	Mortality		Up to 30 days post-operative
Secondary	Length of hospital stay		Up to 30 days post-operative
Secondary	Weight loss		10 days Pre-operative