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

• 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)

• 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

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.

• 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

• (Abstract) ZM Jiang, XR Wang, JM Wei, Y. Wang, Y. Li, S Wang, DW Wilmore. The impact of i.v. fish oil emulsion on clinical outcome & immune functions of post-operative cancer patients: a randomized, double blind, controlled, multi-center clinical trial for 203 cases Clinical Nutrition(Abstract for ESPEN 2005)(Absract No. 181)
• Jiang ZM, Wilmore DW, Wang XR, Wei JM, Zhang ZT, Gu ZY, Wang S, Han SM, Jiang H, Yu K. Randomized clinical trial of intravenous soybean oil alone versus soybean oil plus fish oil emulsion after gastrointestinal cancer surgery. Br J Surg. 2010 Jun;97(6):804-9.

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