Effect of Preoperative Immunonutrition in Upper Digestive Tract
Multicenter Randomized Clinical Trial of the Effect of Preoperative Immunonutrition Versus Standard Enteral Nutrition in Elective Oncological Surgery of the Upper Digestive Tract
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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A Coruña
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Santiago De Compostela, A Coruña, Spain, 15701
- Recruiting
- Miguel A. Martínez Olmos
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Contact:
- Miguel A Martínez Olmos, MD PhD
-
Principal Investigator:
- Miguel A Martínez Olmos, MD PhD
-
Sub-Investigator:
- Ana Cantón Blanco, MD PhD
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Sub-Investigator:
- Rocío Villar Taibo, MD PhD
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Sub-Investigator:
- Alicia Santamaría Nieto, MD
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Sub-Investigator:
- Ana B Crujeiras, BSc PhD
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Sub-Investigator:
- Ana Suárez Rodríguez, BSc
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La Coruna
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A Coruña, La Coruna, Spain, 15006
- Recruiting
- Alfonso Vidal-Casariego
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Contact:
- Alfonso Vidal-Casariego, MD, PhD
- Phone Number: +34981176442
- Email: alfonso.vidal.casariego@sergas.es
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Principal Investigator:
- Alfonso Vidal-Casariego, MD, PhD
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Sub-Investigator:
- Francisco Pita-Gutiérrez, MD, PhD
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Sub-Investigator:
- Gloria Lugo-Rodríguez, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
It is a hypercaloric and hyperproteic dietary supplement formulated with immunonutrients: Arginin, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine
Other Names:
|
|
Placebo Comparator: Standard
Oral nutritional supplement: hypercaloric and hyperproteic without immunonutrients
|
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
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
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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