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Completed

NCT Number: NCT00292279

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Friendship Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 fish oil emulsion (Omegaven )

Drug

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

long-chain triglyceride

Drug

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

Other names: Intralipid

Primary outcomes

  1. Infectious complication

    Time frame: POD+1 to POD+14

  2. Systemic inflammatory response syndrome (SIRS)

    Time frame: POD+1 to POD +8

Secondary outcomes

  1. Post-operative hospitalization days

    Time frame: POD+1 to discharge

  2. Post operative nutritional cost & total treatment cost

    Time frame: POD+1 to discharge

Sponsors and collaborators

Lead sponsor

Sino-Swed Pharmaceutical Corporation

Industry

Registry information

Official study 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.

Important dates

Study start
2002
Primary completion
2003
Study completion
2004
First posted
Feb 15, 2006
Registry last updated
May 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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