GI CancerPhase 3NCT00798447
Efficacy and Safety of a PN Regimen Containing n-3 Fatty Acid in Patients Considered After GI Surgery
A Phase 3 study testing MLF 541 and Lipofundin MCT in people with GI Cancer, run by B. Braun Melsungen AG at 2 sites in Taiwan.
Trial summary
Evaluation of the impact of peri- and post-operative parenteral nutrition enriched with n-3 PUFA on post-operative inflammatory processes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- GI Cancer
- What is being tested?
- MLF 541 and Lipofundin MCT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTaiwan
- Study dates
- Nov 2008to Oct 2010
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients considered for major surgery for gastric and colorectal cancer
- expected requirement for post operative PN or TPN of at least 7 days
- possibility of PN/TPN provision 1 day prior to surgery
- Age >18 years old and <80 years old
- Hemodynamically stable
- Written Informed consent
Who cannot join
- Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to the start of study
- Patients with sepsis, severe sepsis or septic shock
- Known or suspected drug abuse
- Intrahepatic cholestasis
- General contraindications for infusion therapy such as acute pulmonary edema, hyperhydration and decompensated cardiac insufficiency
- Pregnancy (positive in urine) or lactation
Show all 14Show fewer
- Autoimmune disease e.g. HIV
- Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients of the investigational products
- Hemodynamic failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure)
- Alterations of coagulation (thrombocytes <150000 /mm3), PT < 50%, PTT > 40 sec
- Ketoacidosis caused by Diabetes mellitus within 7 days prior to onset of study
- Renal insufficiency with serum creatinine > 1.4 mg/dL (>124 µmol/L)
- Patients with severe liver dysfunction with bilirubin >2.5 mg/dL (> 43 µmol/L)
- Lipid disorders, in particular fasting serum triglycerides > 250 mg/dL (>2.85 mmol/L),
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Medical University Hospital
Kaohsiung City
National Taiwan University Hospital Taipei
Taipei
About this study
Official title: A Prospective, Randomized, Double Blind Study to Compare the Efficacy and Safety of a n-3 Fatty Acid-containing Lipid Emulsion During Parenteral Nutrition in Patients Considered for Major Surgery for Gastric and Colorectal Cancer.
Evaluation of the impact of peri- and post-operative parenteral nutrition enriched with n-3 PUFA on post-operative inflammatory processes.
- Conditions
- GI Cancer
- Being tested
- MLF 541, Lipofundin MCT
- Keywords
- post OP
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLF 541Drug
22-24 h i.v. infusion, maximum 0.75 ml lipid emulsion per kg BW per hour
Lipofundin MCTDrug
22-24 h iv.infusion, maximum 0.75 ml lipid emulsion per kg BW per hour
| Study group | Role | What they receive |
|---|---|---|
| lipid emulsion with n-3 FA | Experimental | Not described Receives: Drug: MLF 541 |
| lipid emulsion without n-3 FA | Active comparator | Not described Receives: Drug: Lipofundin MCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of pro inflammatory activity
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GI CancerStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Taiwan Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798447
- Sponsor's protocol ID
- HC-G-H-0603
- Status last verified
- Jun 2011
- First submitted
- 25 Nov 2008
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ma CJ, Wu JM, Tsai HL, Huang CW, Lu CY, Sun LC, Shih YL, Chen CW, Chuang JF, Wu MH, Wang MY, Lin MT, Wang JY. Prospective double-blind randomized study on the efficacy and safety of an n-3 fatty acid enriched intravenous fat emulsion in postsurgical gastric and colorectal cancer patients. Nutr J. 2015 Jan 21;14:9. doi: 10.1186/1475-2891-14-9.
PubMed 25609264
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double Blind Study to Compare the Efficacy and Safety of a n-3 Fatty Acid-containing Lipid Emulsion During Parenteral Nutrition in Patients Considered for Major Surgery for Gastric and Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT00798447
- Acronym / sponsor ID
- HC-G-H-0603
- Conditions
- GI Cancer
- Keywords
- post OP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Taiwan Co., Ltd.
- Study start
- Nov 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Nov 2008 (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.
Evaluation of the impact of peri- and post-operative parenteral nutrition enriched with n-3 PUFA on post-operative inflammatory processes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lipid emulsion with n-3 FA | Experimental | Drug: MLF 541 |
| lipid emulsion without n-3 FA | Active comparator | Drug: Lipofundin MCT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients considered for major surgery for gastric and colorectal cancer
- expected requirement for post operative PN or TPN of at least 7 days
- possibility of PN/TPN provision 1 day prior to surgery
- Age >18 years old and <80 years old
- Hemodynamically stable
Key exclusion criteria (14 listed)
- Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to the start of study
- Patients with sepsis, severe sepsis or septic shock
- Known or suspected drug abuse
- Intrahepatic cholestasis
- General contraindications for infusion therapy such as acute pulmonary edema, hyperhydration and decompensated cardiac insufficiency
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 |
|---|---|---|
| MLF 54122-24 h i.v. infusion, maximum 0.75 ml lipid emulsion per kg BW per hour | Drug | lipid emulsion with n-3 FA |
| Lipofundin MCT22-24 h iv.infusion, maximum 0.75 ml lipid emulsion per kg BW per hour | Drug | lipid emulsion without n-3 FA |
Primary outcome
reduction of pro inflammatory activity
Time frame: 30 days
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 9 Jun 2011.
- Derived from this study: PubMed 25609264Ma CJ, Wu JM, Tsai HL, Huang CW, Lu CY, Sun LC, Shih YL, Chen CW, Chuang JF, Wu MH, Wang MY, Lin MT, Wang JY. Prospective double-blind randomized study on the efficacy and safety of an n-3 fatty acid enriched intravenous fat emulsion in postsurgical gastric and colorectal cancer patients. Nutr J. 2015 Jan 21;14:9. doi: 10.1186/1475-2891-14-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 MLF 541 and Lipofundin MCT in people with GI Cancer, run by B. Braun Melsungen AG at 2 sites in Taiwan.
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 6 inclusion and 14 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 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
reduction of pro inflammatory activity (time frame: 30 days). 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 NCT00798447, which also lists 1 linked publication.
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 9 Jun 2011.