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

NCT ID: NCT02231203

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-06-30

Brief 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.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Omegaven

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

Group Type: ACTIVE_COMPARATOR

Omegaven

Intervention Type: DRUG

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

Interventions

Omegaven

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

purified fish oil; omega-3 fatty acids; eicosapentaenoicacid (EPA); docosahexaenoicacid (DHA); dl-a- tocopherol (antioxidant); Omegaven-Fresenius; NaCl 0,9%; Natriumchloride 0,9%; glass container NaCl 0,9% Fresenius Kabi

Eligibility 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

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Center Alkmaar

OTHER

Sponsor Role: lead

Responsible Party

Alexander P.J. Houdijk

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

A.P.J. Houdijk, Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical Center of Alkmaar

Locations

Medical Center of Alkmaar

Alkmaar, North Holland, Netherlands

Countries

Netherlands

References

Bakker N, van den Helder RS, Stoutjesdijk E, van Pelt J, Houdijk APJ. Effects of perioperative intravenous omega-3 fatty acids in colon cancer patients: a randomized, double-blind, placebo-controlled clinical trial. Am J Clin Nutr. 2020 Feb 1;111(2):385-395. doi: 10.1093/ajcn/nqz281.

Reference Type: DERIVED

PMID: 31826232 (View on PubMed)

Other Identifiers

NL46230.029.13

Identifier Type: -

Identifier Source: org_study_id