Our primary objective is to study the effect of perioperative intravenous supplementation of omega-3 fatty acids on the perioperative inflammatory response compared to a saline control in patients undergoing surgery for colon cancer.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To study the effect of perioperative intravenous administration of omega-3
fatty acids on the immune response of patients undergoing laparoscopic surgery
for colon cancer, by measuring the ex vivo production of pro-inflammatory
cytokine IL-6 in LPS stimulated whole blood.
Secondary outcome
To study:
* The effect of intravenous omega-3 fatty acids on the production of TNF-* and
IL-10 in ex vivo LPS stimulated whole blood.
* The effect of intravenous omega-3 fatty acids on erythrocyte function.
* The effect of intravenous omega-3 fatty acids on the in vivo systemic
inflammatory response, including white blood cell count, C-reactive protein and
cytokine levels in serum.
* The effect of intravenous omega-3 fatty acids on postoperative outcome.
* The effect of intravenous omega-3 fatty acids on cognition
Background 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. Erythrocyte function can be assessed
measuring erythrocyte deformability, osmotic resilience and aggregation.
We 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.
Study objective
Our primary objective is to study the effect of perioperative intravenous
supplementation of omega-3 fatty acids on the perioperative inflammatory
response compared to a saline control in patients undergoing surgery for colon
cancer.
Study design
A randomized, double blind, placebo-controlled study at the Surgery Department
of the Medical Centre Alkmaar.
Intervention
Omegaven-Fresenius, a 10% fish-oil emulsion containing the omega-3 fatty acids
EPA and DHA. The dosage per infusion will be 2ml/kg, one infusion in 4 hours
the evening before the operation, and one infusion in 4 hours de morning after
the operation day.
Study burden and risks
Omega-3 fatty acids can safely be administrated up to 0.2 g/kg BW/day. The
burden is related to the intravenous administration during two separate time
courses of 4 hours and the extra venous blood samples that will be drawn.
Possible risks are side effects of Omegaven and flebitis. The possible benefit
of the study is related to the effect of omega-3 fatty acids.
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Listed location countries
Age
Inclusion criteria
*Patients (male or female) undergoing elective laparoscopic surgery for colon cancer
*Age between 55 and 85 years
*BMI between 20 and 35 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
*Bleeding disorders, determined by medical history and laboratory tests of clotting indices
*Metastatic disease
*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-indication(s) for the use of Omegaven.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-003664-32-NL |
| CCMO | NL46230.029.13 |