Carcinoma SurgeryPhase 3NCT00292279
The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients
A Phase 3 study testing Omega-3 fish oil emulsion (Omegaven ) and long-chain triglyceride in people with Carcinoma Surgery and Parenteral Nutrition, run by Sino-Swed Pharmaceutical Corporation at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carcinoma Surgery, Parenteral Nutrition, Post-Operative Hospital Stay
- What is being tested?
- Omega-3 fish oil emulsion (Omegaven ) and long-chain triglyceride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 5 sitesChina
- Study dates
- Jun 2002to Feb 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
People's Hospital, Beijing University
Beijing, 100044
Beijing Friendship Hospital
Beijing, 100050
Beijing Hospital
Beijing, 100730
Peking Union Medical College Hospital
Beijing, 100730
General Hospital Of PLA
Beijing, 100853
About this study
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.
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.
Read the 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.
- Being tested
- Omega-3 fish oil emulsion (Omegaven ), long-chain triglyceride
- 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
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fish oil emulsion (Omegaven )Drug
Also called 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
long-chain triglycerideDrug
Also called Intralipid
the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Omega-3 fish oil emulsion (Omegaven ) |
| B | Active comparator | Not described Receives: Drug: long-chain triglyceride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious complication
Measured: POD+1 to POD+14
Systemic inflammatory response syndrome (SIRS)
Measured: POD+1 to POD +8
Secondary outcomes (2)
Post-operative hospitalization days
Measured: POD+1 to discharge
Post operative nutritional cost & total treatment cost
Measured: POD+1 to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startJun 2002
- Primary completionNov 2003
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sino-Swed Pharmaceutical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Zhu-ming Jiang, FACS, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292279
- Sponsor's protocol ID
- HL20020004
- Status last verified
- May 2008
- First submitted
- 13 Feb 2006
- Last updated
- 14 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
(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. doi: 10.1002/bjs.6999.
PubMed 20473991
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00292279
- Acronym / sponsor ID
- HL20020004
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Sino-Swed Pharmaceutical CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Nov 2003 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 15 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Omega-3 fish oil emulsion (Omegaven ) |
| B | Active comparator | Drug: long-chain triglyceride |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fish oil emulsion (Omegaven )Also: OmegavenPatients 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 | Drug | A |
| long-chain triglycerideAlso: Intralipidthe control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China) | Drug | B |
Primary outcome
Infectious complication
Time frame: POD+1 to POD+14
Systemic inflammatory response syndrome (SIRS)
Time frame: POD+1 to POD +8
2 secondary outcomes
Post-operative hospitalization days
Time frame: POD+1 to discharge
Post operative nutritional cost & total treatment cost
Time frame: POD+1 to discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2008.
- Results publication(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)
- Derived from this study: PubMed 20473991Jiang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhu-ming Jiang, FACS study director
Peking Union Medical College Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega-3 fish oil emulsion (Omegaven ) and long-chain triglyceride in people with Carcinoma Surgery and Parenteral Nutrition, run by Sino-Swed Pharmaceutical Corporation at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infectious complication (time frame: POD+1 to POD+14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00292279, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2008.