Patients undergoing colon surgery for malignancy. MedDRA version: 17.0 Level: LLT Classification code 10009951 Term: Colon cancer NOS System Organ Class: 100000004864 MedDRA version: 17.0 Level: LLT Classification code 10009950 Term: Colon cancer Duke's D System Organ Class: 100000004864 MedDRA version: 17.0 Level: LLT Classification code 10009946 Term: Colon cancer Duke's A System Organ Class: 100000004864 MedDRA version: 17.0 Level: LLT Classification code 10009947 Term: Colon cancer Duke'
Conditions
Interventions
Trade Name: Omegaven-Fresenius
Pharmaceutical Form: Emulsion for infusion
Sponsors
Medical Center Alkmaar
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients (male or female) undergoing elective laparoscopic surgery for colon cancer •Age between 60 and 80 years •BMI between 20 kg/m2 and below 30 kg/m2 •Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: •Participation in or having participated in another clinical trial within the previous 3 months •Indications for continuously use of anticoagulant medication and no possibility to stop these medication perioperatively, for example patients with an artificial heart valve •Bleeding disorders, determined by medical history and laboratory tests of clotting indices •Metastatic disease •Recent cardiac or cerebral infarction within the last 6 months •Current history of inflammatory or infectious disease •The use of anti-inflammatory drugs •The use of thyroid medication •The use of fish oil products or fish consumption more than 2 times a week •Contra-indications for the use of Omegaven-Fresenius
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of intravenous Omegaven® on the production of cytokine interleukin-6 in ex vivo LPS stimulated whole blood cells in patients undergoing laparoscopic surgery for colon cancer, compared to an intravenous saline treated control group. ;Primary end point(s): The main study parameter is the ex-vivo production of pro-inflammatory cytokine IL-6 in LPS stimulated whole blood cells ;Timepoint(s) of evaluation of this end point: The second postoperative day.;Secondary Objective: •The effect of intravenous Omegaven® on the production of cytokines TNF-a and Interleukin-10 in ex vivo LPS stimulated whole blood cells. •The effect of intravenous Omegaven® on erythrocyte function. •The effect of intravenous Omegaven® on the in vivo systemic inflammatory response, including white blood cell count, C-reactive protein and cytokine levels in serum. •The effect of intravenous Omegaven® on mRNA expression of NFKappaB and IKappaB in leucocytes. •The effect of intravenous Omegaven® on perioperative plasma glutamine levels. •The effect of intravenous Omegaven® on postoperative outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Levels of TNF-a and IL-10 in whole blood cells after stimulation with LPS •Erythrocyte function, measured as o deformability o aggregability •Systemic inflammatory cytokine response measured as plasma levels of: oC-reactive protein oWBC oCytokines TNF-a, IL-6 and IL-10 The effect of surgery on cognitive function The effect of omega-3 fatty acids on cognitive function ;Timepoint(s) of evaluation of this end point: Blood samples for ex vivo whole blood stimulation, erythrocyte function, plasma cytokines and other plasma measures are drawn on 6 time points (T=1 is 8 am the day before surgery (day=-1), T=2 is at the start of surgery (day =0), T=3 is 1 hr after the start of surgery (day =0), T=4, 5, and 6 are at 8 am on the first, second and fourth postoperative day). | — |
Countries
Netherlands
Contacts
Public ContactTrial Center Holland Health
Medical Center Alkmaar
Outcome results
None listed