Randomized Double Blinded Trial to Investigate Effects of an Enteral Nutritional Supplement Enriched With Eicosapentaenoic Acid on Body Composition,Complications,Stress Response,Immune Function & Quality of Life in After Esophagectomy
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Preservation of body compostition after surgery
研究概览
简要总结
This study aims to examine whether providing tube feeding with a formula enriched with omega-3 fats is better than traditional standard tube feeding in terms of preserving nutritional status, improving immune function and reducing medical complications following major upper Gut cancer surgery.
详细描述
Title A double blinded randomized controlled trial to investigate the effects of an enteral nutritional supplement enriched with Eicosapentaenoic acid on long term nutritional status post operatively specifically the maintenance of lean body mass, and its potential impact on quality of life as well as examining the stress response and immune function and in patients undergoing surgical treatment of esophageal cancer.
Investigational medicinal Product(s):
Prosure (Abbott Laboratories)
Comparator:
Ensure Plus (Abbott Laboratories)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (male & female) patients >18 years with resectable esophageal cancer
排除标准
- •Patients with metastatic disease,
- •Non-operable cases,
- •Patients requiring chemotherapy/radiotherapy early following surgery,
- •Patients with known immunological disorder,
- •Emergency esophagectomy cases,
- •Patients with cardiac, liver or renal failure,
- •Active small intestinal disease eg Crohns disease,
- •Allergy to any of the ingredients,
- •Uncontrollable Diabetes,
- •Use of medications known to affect eicosanoid metabolism in two weeks prior to trial,
- •Use of fish oil/n-3 fatty acids,
- •Drug Abuse,
- •Unable to take preparation for 5 days preoperatively,
- •Pregnant women,
- •Cessation of enteral feeding for longer than 3 consecutive days post operatively for medical/surgical reasons (e.g. Chyle leaks).
结局指标
主要结局
Preservation of body compostition after surgery
时间窗: 2 months
次要结局
- Reduced immuno-inflammatory response to surgery(2 months)