The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients: A Randomized, Double Blind, Controlled, Multi-Center Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 5
- 主要终点
- Infectious complication
研究概览
简要总结
The purpose of this study is to evaluate clinical safety and effect of Omega-3 fat oil emulsion on outcome in post-operative cancer patients.
详细描述
As an essential component of parenteral nutrition, fat emulsion has been used more than 30 years. It provides energy and essential fatty acids. Commercial fatty emulsion products mostly come from soy bean. The omega 6 fatty acids make up with the major fatty acids of this fat emulsion, and lack of omega 3 fatty acids generally. The imbalance of these two types of fatty acids may impact with negative clinical outcomes.
There are lots of omega 3 fatty acids makes up with fish oil emulsion, especially with eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA).Few clinical studies found its clinical efficacy in recently years. A commercial product of omega 3 fat emulsion by Fresenius-Kabi was registered in Europe at 1998. There is no any clinical trial in Asia to elaborate the efficacy of omega 3 fat emulsion, as well the lack of large scale clinical trial in the world.
Currently study is the first large scale, randomized, double blind and multi-center clinical trial to elaborate the impact of fish oil fat emulsion in Asia and Europe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-operative male and female cancer patients
- •Require post operative parenteral nutrition support at least 7 days based on nutritional risk screening(BMI 20-25)
- •Sign an informed consent
排除标准
- •Diabetes Mellitus
- •Abnormal fatty metabolism (TG>200mg/dl or cholesterol>240mg/dl )
- •Renal dysfunction (Cr>1.6mg/dl or BUN>30mg/dl)
- •Liver dysfunction (ALT>60U/L or TBIL>1.2mg/dl)
- •Lienectomy
- •Temperature>37.5°C
- •Undergoing hormone therapy
- •Pregnancy
研究组 & 干预措施
A
干预措施: Omega-3 fish oil emulsion (Omegaven ) (Drug)
B
干预措施: long-chain triglyceride (Drug)
结局指标
主要结局
Infectious complication
时间窗: POD+1 to POD+14
Systemic inflammatory response syndrome (SIRS)
时间窗: POD+1 to POD +8
次要结局
- Post-operative hospitalization days(POD+1 to discharge)
- Post operative nutritional cost & total treatment cost(POD+1 to discharge)