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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2004-02-29

Brief Summary

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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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Detailed Description

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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.

Conditions

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Carcinoma Surgery Parenteral Nutrition Post-Operative Hospital Stay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

Omega-3 fish oil emulsion (Omegaven )

Intervention Type 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

B

Group Type ACTIVE_COMPARATOR

long-chain triglyceride

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

long-chain triglyceride

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

Intervention Type DRUG

Other Intervention Names

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Omegaven Intralipid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No