Clinical trial NCT00292279: The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients
Official title: The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients: A Randomized, Double Blind, Controlled, Multi-Center Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma Surgery
Parenteral Nutrition
Post-Operative Hospital Stay
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
Lead sponsor: Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
Sponsor class: INDUSTRY
First posted: 2006-02-15
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Infectious complication
timeFrame: POD+1 to POD+14
measure: Systemic inflammatory response syndrome (SIRS)
timeFrame: POD+1 to POD +8
Secondary outcomes:
measure: Post-operative hospitalization days
timeFrame: POD+1 to discharge
measure: Post operative nutritional cost & total treatment cost
timeFrame: POD+1 to discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: People's Hospital, Beijing University
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: General Hospital Of PLA
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhu-ming Jiang, FACS
role: STUDY_DIRECTOR
References:
citation: (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)
citation: 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. doi: 10.1002/bjs.6999.