Effect of Preoperative Immunonutrition in Upper Digestive Tract
关键词
抽象
描述
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).
日期
| 最后验证: | 07/31/2019 |
| 首次提交: | 07/15/2019 |
| 提交的预估入学人数: | 07/17/2019 |
| 首次发布: | 07/18/2019 |
| 上次提交的更新: | 08/18/2019 |
| 最近更新发布: | 08/19/2019 |
| 实际学习开始日期: | 08/09/2019 |
| 预计主要完成日期: | 08/09/2021 |
| 预计完成日期: | 12/30/2021 |
状况或疾病
干预/治疗
Dietary Supplement: Immunonutrition
Dietary Supplement: Standard
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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 |
| 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 |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Infectious complications [Up to 30 days post-operative]
2. Surgical fistulas [Up to 30 days post-operative]
次要成果指标
1. Mortality [Up to 30 days post-operative]
2. Length of hospital stay [Up to 30 days post-operative]
3. Weight loss [10 days Pre-operative]
