Parenteral Nutrition Clinical Trial
Official title:
The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients: A Randomized, Double Blind, Controlled, Multi-Center Clinical Trial.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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