Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292279
Status:
COMPLETED
Last Update Posted:
2008-05-14
First Post:
2006-02-13
Brief Title:
The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients
Sponsor:
Sino-Swed Pharmaceutical Corporation
Organization:
Fresenius Kabi Sino-Swed Pharmaceutical Corp Ltd
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 DHAFew 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
There are lots of omega 3 fatty acids makes up with fish oil emulsion especially with eicosapentaenoic acid EPA and Docosahexaenoic acid DHAFew 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None