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The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Sino-Swed Pharmaceutical Corporation
ClinicalTrials.gov Identifier:
NCT00292279
First received: February 13, 2006
Last updated: May 12, 2008
Last verified: May 2008

February 13, 2006
May 12, 2008
June 2002
November 2003   (final data collection date for primary outcome measure)
  • Infectious complication [ Time Frame: POD+1 to POD+14 ] [ Designated as safety issue: Yes ]
  • Systemic inflammatory response syndrome (SIRS) [ Time Frame: POD+1 to POD +8 ] [ Designated as safety issue: Yes ]
  • Infectious complication
  • Systemic inflammatory response syndrome (SIRS)
Complete list of historical versions of study NCT00292279 on ClinicalTrials.gov Archive Site
  • Post-operative hospitalization days [ Time Frame: POD+1 to discharge ] [ Designated as safety issue: Yes ]
  • Post operative nutritional cost & total treatment cost [ Time Frame: POD+1 to discharge ] [ Designated as safety issue: Yes ]
  • Post-operative hospitalization days
  • Nutritional and total post-operative medical cost
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Carcinoma Surgery
  • Parenteral Nutrition
  • Post-Operative Hospital Stay
  • 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 Name: Omegaven
  • Drug: long-chain triglyceride
    the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China)
    Other Name: Intralipid
  • Experimental: A
    Intervention: Drug: Omega-3 fish oil emulsion (Omegaven )
  • Active Comparator: B
    Intervention: Drug: long-chain triglyceride

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
February 2004
November 2003   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00292279
HL20020004
Yes
TF Ye, Ethic Committee of Peking Union Medical College Hospital
Sino-Swed Pharmaceutical Corporation
Not Provided
Study Director: Zhu-ming Jiang, FACS Peking Union Medical College Hospital
Sino-Swed Pharmaceutical Corporation
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP