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Effect of Preoperative Immunonutrition in Upper Digestive Tract

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ClinicalTrials.gov Identifier: NCT04027088
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Alfonso Vidal Casariego, Complexo Hospitalario Universitario de A Coruña

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.

Condition or disease Intervention/treatment Phase
Immunonutrition Gastric Cancer Esophageal Cancer Pancreas Cancer Surgery--Complications Dietary Supplement: Immunonutrition Dietary Supplement: Standard Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : August 10, 2019
Estimated Primary Completion Date : August 10, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Infectious complications [ Time Frame: Up to 30 days post-operative ]
  2. Surgical fistulas [ Time Frame: Up to 30 days post-operative ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: Up to 30 days post-operative ]
  2. Length of hospital stay [ Time Frame: Up to 30 days post-operative ]
  3. Weight loss [ Time Frame: 10 days Pre-operative ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027088


Contacts
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Contact: Alfonso Vidal-Casariego, PhD, MD +34981176442 alfonso.vidal.casariego@sergas.es

Locations
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Spain
Miguel A. Martínez Olmos Recruiting
Santiago De Compostela, A Coruña, Spain, 15701
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         
Alfonso Vidal-Casariego Recruiting
A Coruña, La Coruna, Spain, 15006
Contact: Alfonso Vidal-Casariego, MD, PhD    +34981176442    alfonso.vidal.casariego@sergas.es   
Principal Investigator: Alfonso Vidal-Casariego, MD, PhD         
Sub-Investigator: Francisco Pita-Gutiérrez, MD, PhD         
Sub-Investigator: Gloria Lugo-Rodríguez, MD         
Sponsors and Collaborators
Complexo Hospitalario Universitario de A Coruña
Investigators
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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

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Responsible Party: Alfonso Vidal Casariego, Dr. Alfonso Vidal Casariego, MD PhD, Complexo Hospitalario Universitario de A Coruña
ClinicalTrials.gov Identifier: NCT04027088     History of Changes
Other Study ID Numbers: 2018/548
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alfonso Vidal Casariego, Complexo Hospitalario Universitario de A Coruña:
immunonutrition
surgery
postoperative complications
length of hospital stay
nutritional status
Additional relevant MeSH terms:
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Digestive System Neoplasms
Digestive System Diseases
Pancreatic Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs