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

Medical Center Alkmaar

Status and phase: Completed; Phase 4

Conditions: Colon Cancer

Treatments: Drug: Placebo; Drug: Omegaven

Study type: Interventional

Funder types: Other

Identifiers

NCT02231203

NL46230.029.13

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

2 infusions of NaCl, 2 ml/kg, one the night before operation and one the day after operation.

Treatment:

Drug: Placebo

Omegaven

Active Comparator group

Description:

2 infusions of 2ml/kg, one the night before surgery and one the day after surgery

Treatment:

Drug: Omegaven