Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function

Colon Cancer Clinical Trial

— EMPIRE  

Official title:

Effect of Intravenous Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function in Patients With Colon Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231203
• Other study ID #: NL46230.029.13
• Status: Completed
• Phase: Phase 4
• Start date: October 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2018
• Source: Medical Center Alkmaar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ideally, the postoperative inflammatory response is part of a well-orchestrated mechanism that contributes to tissue healing and rapid recovery. An exaggerated uncontrolled inflammatory response, however may lead to catabolism, tissue damage and organ failure. Omega-3 fatty acids may provide a means to alter cellular immune responses to the benefit of the patient. When omega-3 fatty acids are incorporated into membranes of inflammatory cells, they trigger intracellular signalling pathways that result in a less pro-inflammatory response. They modify gene and protein expression, modulate membrane protein activity and act as a reservoir for bioactive molecules. They also have a strong anti-inflammatory effect by mediating resolution of the inflammation. Furthermore, omega-3 fatty acids improve erythrocyte function, which is vital for an adequate microcirculation, tissue oxygenation and wound healing.

The investigators hypothesize that the perioperative administration of intravenous omega-3 fatty acids results in a rapid incorporation in immune cells and erythrocytes, thereby reducing the postoperative inflammatory response and improving erythrocyte function in patients undergoing colorectal surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

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

• Pre-operative Hemoglobin<5.0 mmol/L

• Metastatic disease

• Very poor peripheral venous access

• 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-indication for the use of Omegaven-Fresenius, including:

• General contra-indications for parenteral nutrition

• Allergy to fish or egg protein.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Drug:
• Omegaven
2 infusions, 2 ml/kg, one the night before operation and one the day after operation
• Placebo
2 infusions, 2 ml/kg, one the night before operation and one the day after operation

Locations

Country	Name	City	State
Netherlands	Medical Center of Alkmaar	Alkmaar	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
Medical Center Alkmaar

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative outcome (composite measure of length of stay and complications)	Length of hospital stay and occurence of surgical site infection, abscess, urinary tract infection, pneumonia, anastomotic leakage, need for Intensive Care Unit admission, Systemic Inflammatory Response Syndrome, Multi Organ Failure, any adverse events.	Registration during admission, follow up 2 and 4 weeks after surgery
Other	Cognitive function	Neuropsychological examination using a reading test, an auditory verbal learning test, WAIS III figure series and trail making tests.	baseline, follow up 2 weeks after surgery
Primary	Change in ex vivo production of pro-inflammatory cytokine IL-6 in LPS stimulated whole blood	Ex vivo stimulation of whole blood with LPS (lipopolysaccharide, component of gram negative bacteria) resulting in the production of the pro-inflammatory cytokine IL-6, measured in ng/ml.	baseline, day of surgery, postoperative day 1,2 and 4
Secondary	Change in ex vivo production of TNF-a and IL-10 in LPS stimulated whole blood	Ex vivo stimulation of whole blood with LPS (lipopolysaccharide, component of gram negative bacteria) resulting in the production of the pro-inflammatory cytokine TNF-a (tumor necrosis factor-a), and the anti-inflammatory cytokine IL-10 (interleukine-10), both measured in ng/ml.	baseline, day of surgery, postoperative day 1, 2 and 4
Secondary	Change in erythrocyte function	Erythrocyte deformability and aggregation measured by LORRCA (laser assisted optical rotational red cell analyzer)	baseline, day of surgery, postoperative day 1, 2 and 4
Secondary	Change in in vivo systemic inflammatory response parameters	White blood cell count, C-reactive protein and cytokine levels (Interleukine-6, Tumor Necrosis Factor-a and Interleukine-10) in serum.	baseline, day of surgery, postoperative day 1, 2 and 4