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

Study Overview
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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.

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.

Official Title
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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.

Conditions
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Carcinoma Surgery, Parenteral Nutrition, Post-Operative Hospital Stay

Intervention / Treatment
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* Drug: Omega-3 fish oil emulsion (Omegaven )
* Drug: long-chain triglyceride


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Omega-3 fish oil emulsion (Omegaven )<br>* 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<br>* Other names: Omegaven;|
| Active Comparator: B<br> | Drug: long-chain triglyceride<br>* the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China)<br>* Other names: Intralipid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious complication |  | POD+1 to POD+14 | 
| Systemic inflammatory response syndrome (SIRS) |  | POD+1 to POD +8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative hospitalization days |  | POD+1 to discharge | 
| Post operative nutritional cost & total treatment cost |  | POD+1 to discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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