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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunonutrition | Experimental | Oral nutritional supplement: hypercaloric and hyperproteic with immunonutrients: Arginine, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine |
|
| Standard | Placebo Comparator | Oral nutritional supplement: hypercaloric and hyperproteic without immunonutrients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunonutrition | Dietary Supplement | It is a hypercaloric and hyperproteic dietary supplement formulated with immunonutrients: Arginin, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine |
| Measure | Description | Time Frame |
|---|---|---|
| Infectious complications | Up to 30 days post-operative | |
| Surgical fistulas | Up to 30 days post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Up to 30 days post-operative | |
| Length of hospital stay | Up to 30 days post-operative | |
| Weight loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alfonso Vidal-Casariego, PhD, MD | Contact | +34981176442 | alfonso.vidal.casariego@sergas.es |
| Name | Affiliation | Role |
|---|---|---|
| Miguel Á Martínez-Olmos, PhD, MD | Complexo Hospitalario Universitario de Santiago | Principal Investigator |
| Alfonso Vidal-Casariego, PhD, MD | Complexo Hospitalario Universitario de A Coruña | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miguel A. Martínez Olmos | Recruiting | Santiago de Compostela | A Coruña | 15701 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38863591 | Derived | Villar-Taibo R, Vidal-Casariego A, Santamaria-Nieto A, Canton-Blanco A, Crujeiras AB, Lugo Rodriguez G, Rodriguez-Carnero G, Pita Gutierrez F, Fernandez Pombo A, Diaz-Lopez E, Roman Eyo A, Rodriguez Lavandeira U, Pena-Dubra A, Martinez-Olmos MA. Efficacy of a new immunonutrition formula with extra virgin olive oil in the reduction of complications in surgeries of upper digestive tract tumors. Front Nutr. 2024 May 28;11:1384145. doi: 10.3389/fnut.2024.1384145. eCollection 2024. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093702 | Immunonutrition Diet |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| Standard | Dietary Supplement | It is a hypercaloric and hyperproteic dietary supplement formulated without immunonutrients |
|
| 10 days Pre-operative |
| Alfonso Vidal-Casariego | Recruiting | A Coruña | La Coruna | 15006 | Spain |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |