Multicenter Randomized Clinical Trial of the Effect of Preoperative Immunonutrition Versus Standard Enteral Nutrition in Elective Oncological Surgery of the Upper Digestive Tract
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 178
- 试验地点
- 4
- 主要终点
- Infectious complications
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cancer of esophagus, stomach and / or pancreas, at any stage, proposed for surgery
- •Signing informed consent
排除标准
- •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
研究组 & 干预措施
Immunonutrition
Oral nutritional supplement: hypercaloric and hyperproteic with immunonutrients: Arginine, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine
干预措施: Immunonutrition (Dietary Supplement)
Standard
Oral nutritional supplement: hypercaloric and hyperproteic without immunonutrients
干预措施: Standard (Dietary Supplement)
结局指标
主要结局
Infectious complications
时间窗: Up to 30 days post-operative
Surgical fistulas
时间窗: Up to 30 days post-operative
次要结局
- Length of hospital stay(Up to 30 days post-operative)
- Weight loss(10 days Pre-operative)
- Mortality(Up to 30 days post-operative)
研究者
Alfonso Vidal Casariego
Dr. Alfonso Vidal Casariego, MD PhD
Complexo Hospitalario Universitario de A Coruña