Trial | NCT00292279  Report issue

Title

The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients
The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients: A Randomized, Double Blind, Controlled, Multi-Center Clinical Trial.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    206
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.
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.
Study Started
Jun 30
2002
Primary Completion
Nov 30
2003
Study Completion
Feb 29
2004
Last Update
May 14
2008
Estimate

Drug Omega-3 fish oil emulsion (Omegaven )

Patients of the treatment group received 0.2 g fish oil (10% Omegaven, Fresenius Kabi, Bad Homburg, Germany) and 1.0 g soy bean oil per kg BW per day

  • Other names: Omegaven

Drug long-chain triglyceride

the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China)

  • Other names: Intralipid

A Experimental

B Active Comparator

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted