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Effect of Preoperative Immunonutrition in Upper Digestive Tract
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Immunonutrition Gastric Cancer Esophageal Cancer Pancreas Cancer Surgery--Complications | Dietary Supplement: Immunonutrition Dietary Supplement: Standard | Not Applicable |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Immunonutrition
Oral nutritional supplement: hypercaloric and hyperproteic with immunonutrients: Arginine, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine
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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
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Placebo Comparator: Standard
Oral nutritional supplement: hypercaloric and hyperproteic without immunonutrients
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Dietary Supplement: Standard
It is a hypercaloric and hyperproteic dietary supplement formulated without immunonutrients
|
- Infectious complications [ Time Frame: Up to 30 days post-operative ]
- Surgical fistulas [ Time Frame: Up to 30 days post-operative ]
- Mortality [ Time Frame: Up to 30 days post-operative ]
- Length of hospital stay [ Time Frame: Up to 30 days post-operative ]
- Weight loss [ Time Frame: 10 days Pre-operative ]
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Contact: Alfonso Vidal-Casariego, PhD, MD | +34981176442 | alfonso.vidal.casariego@sergas.es |
| 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 | |
| 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 |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 16, 2019 | ||||||
| First Posted Date ICMJE | July 19, 2019 | ||||||
| Last Update Posted Date | August 20, 2019 | ||||||
| Actual Study Start Date ICMJE | August 10, 2019 | ||||||
| Estimated Primary Completion Date | August 10, 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Effect of Preoperative Immunonutrition in Upper Digestive Tract | ||||||
| Official Title ICMJE | Multicenter Randomized Clinical Trial of the Effect of Preoperative Immunonutrition Versus Standard Enteral Nutrition in Elective Oncological Surgery of the Upper Digestive Tract | ||||||
| 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. | ||||||
| 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 ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE |
178 | ||||||
| Original Estimated Enrollment ICMJE |
186 | ||||||
| Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||
| Estimated Primary Completion Date | August 10, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Spain | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04027088 | ||||||
| Other Study ID Numbers ICMJE | 2018/548 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Alfonso Vidal Casariego, Complexo Hospitalario Universitario de A Coruña | ||||||
| Study Sponsor ICMJE | Complexo Hospitalario Universitario de A Coruña | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Complexo Hospitalario Universitario de A Coruña | ||||||
| Verification Date | August 2019 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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