Carcinoma Surgery, Parenteral Nutrition, Post-Operative Hospital Stay
Conditions
Keywords
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
Brief summary
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
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.
Interventions
DRUGOmega-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
the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China)
Sponsors
Sino-Swed Pharmaceutical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infectious complication | POD+1 to POD+14 |
| Systemic inflammatory response syndrome (SIRS) | POD+1 to POD +8 |
Secondary
| Measure | Time frame |
|---|---|
| Post-operative hospitalization days | POD+1 to discharge |
| Post operative nutritional cost & total treatment cost | POD+1 to discharge |
Countries
China
Outcome results
None listed