Effect of Preoperative Immunonutrition in Upper Digestive Tract

August 19, 2019 updated by: Alfonso Vidal Casariego, Complexo Hospitalario Universitario de A Coruña

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15701
        • Recruiting
        • Miguel A. Martínez Olmos
        • Contact:
          • Miguel A Martínez Olmos, MD PhD
        • Principal Investigator:
          • Miguel A Martínez Olmos, MD PhD
        • Sub-Investigator:
          • Ana Cantón Blanco, MD PhD
        • Sub-Investigator:
          • Rocío Villar Taibo, MD PhD
        • Sub-Investigator:
          • Alicia Santamaría Nieto, MD
        • Sub-Investigator:
          • Ana B Crujeiras, BSc PhD
        • Sub-Investigator:
          • Ana Suárez Rodríguez, BSc
    • La Coruna
      • A Coruña, La Coruna, Spain, 15006
        • Recruiting
        • Alfonso Vidal-Casariego
        • Contact:
        • Principal Investigator:
          • Alfonso Vidal-Casariego, MD, PhD
        • Sub-Investigator:
          • Francisco Pita-Gutiérrez, MD, PhD
        • Sub-Investigator:
          • Gloria Lugo-Rodríguez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immunonutrition
Oral nutritional supplement: hypercaloric and hyperproteic with immunonutrients: Arginine, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine
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
Other Names:
  • Bi1 procare
Placebo Comparator: Standard
Oral nutritional supplement: hypercaloric and hyperproteic without immunonutrients
Dietary supplement: Standard
It is a hypercaloric and hyperproteic dietary supplement formulated without immunonutrients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infectious complications
Time Frame: Up to 30 days post-operative
Up to 30 days post-operative
Surgical fistulas
Time Frame: Up to 30 days post-operative
Up to 30 days post-operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: Up to 30 days post-operative
Up to 30 days post-operative
Length of hospital stay
Time Frame: Up to 30 days post-operative
Up to 30 days post-operative
Weight loss
Time Frame: 10 days Pre-operative
10 days Pre-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Complexo Hospitalario Universitario de A Coruña

Investigators

  • Principal Investigator: Miguel Á Martínez-Olmos, PhD, MD, Complexo Hospitalario Universitario De Santiago
  • Principal Investigator: Alfonso Vidal-Casariego, PhD, MD, Complexo Hospitalario Universitario de A Coruña

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2019

Primary Completion (Anticipated)

August 10, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 19, 2019

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 19, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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