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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 3
18 Years
70 Years
Not Enrolling
Both
Carcinoma Surgery, Parenteral Nutrition, Post-Operative Hospital Stay

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Infectious complication

Outcome Time Frame:

POD+1 to POD+14

Safety Issue:

Yes

Principal Investigator

Zhu-ming Jiang, FACS

Investigator Role:

Study Director

Investigator Affiliation:

Peking Union Medical College Hospital

Authority:

China: Food and Drug Administration

Study ID:

HL20020004

NCT ID:

NCT00292279

Start Date:

June 2002

Completion Date:

February 2004

Related Keywords:

  • Carcinoma Surgery
  • Parenteral Nutrition
  • Post-Operative Hospital Stay
  • Impact of Omega 3 fatty acid on outcome
  • Omega-3 fatty acid
  • Carcinoma surgery
  • Digestive System
  • Parenteral Nutrition
  • Fat Emulsions, Intravenous
  • Clinical outcome
  • SIRS
  • Infectious complication
  • Postoperative hospital stay
  • Cost of postoperative period
  • Post-operative nutritional cost & total treatment cost
  • Carcinoma

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