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

Sino-Swed Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Post-Operative Hospital Stay; Carcinoma Surgery; Parenteral Nutrition

Treatments: Drug: long-chain triglyceride; Drug: Omega-3 fish oil emulsion (Omegaven )

Study type: Interventional

Funder types: Industry

Identifiers

NCT00292279

HL20020004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 206 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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206 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Omega-3 fish oil emulsion (Omegaven )

B

Active Comparator group

Treatment:

Drug: long-chain triglyceride