Colon CancerPhase 4EMPIRENCT02231203
Effect of Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function
A Phase 4 study testing Omegaven in people with Colon Cancer, run by Medical Center Alkmaar at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Omegaven
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2014to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function in Patients With Colon Cancer
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
- Being tested
- Omegaven, Placebo
- Keywords
- fish oil, omega-3 fatty acids, postoperative inflammatory response, erythrocyte function
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegavenDrug
Also called purified fish oil, omega-3 fatty acids, eicosapentaenoicacid (EPA), docosahexaenoicacid (DHA)
2 infusions, 2 ml/kg, one the night before operation and one the day after operation
PlaceboDrug
Also called NaCl 0,9%, Natriumchloride 0,9%, glass container NaCl 0,9% Fresenius Kabi
2 infusions, 2 ml/kg, one the night before operation and one the day after operation
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 infusions of NaCl, 2 ml/kg, one the night before operation and one the day after operation. Receives: Drug: Placebo |
| Omegaven | Active comparator | 2 infusions of 2ml/kg, one the night before surgery and one the day after surgery Receives: Drug: Omegaven |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, day of surgery, postoperative day 1,2 and 4
Secondary outcomes (3)
Change in ex vivo production of TNF-α 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-α (tumor necrosis factor-α), and the anti-inflammatory cytokine IL-10 (interleukine-10), both measured in ng/ml.
Measured: baseline, day of surgery, postoperative day 1, 2 and 4
Change in erythrocyte function
Erythrocyte deformability and aggregation measured by LORRCA (laser assisted optical rotational red cell analyzer)
Measured: baseline, day of surgery, postoperative day 1, 2 and 4
Change in in vivo systemic inflammatory response parameters
White blood cell count, C-reactive protein and cytokine levels (Interleukine-6, Tumor Necrosis Factor-α and Interleukine-10) in serum.
Measured: baseline, day of surgery, postoperative day 1, 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Center Alkmaar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander P.J. Houdijk, Medical Center Alkmaar
- Investigators
- A.P.J. Houdijk, Dr., Principal investigator, Medical Center of Alkmaar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231203
- Sponsor's protocol ID
- NL46230.029.13
- Acronym
- EMPIRE
- Status last verified
- Jul 2018
- First submitted
- 29 Jul 2014
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31826232
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Omega-3 Fatty Acids on the Perioperative Immune Response and Erythrocyte Function in Patients With Colon Cancer
- ClinicalTrials.gov ID
- NCT02231203
- Acronym / sponsor ID
- EMPIRE / NL46230.029.13
- Conditions
- Colon Cancer
- Keywords
- fish oil, omega-3 fatty acids, postoperative inflammatory response, erythrocyte function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medical Center AlkmaarUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo2 infusions of NaCl, 2 ml/kg, one the night before operation and one the day after operation. |
| Omegaven | Active comparator | Drug: Omegaven2 infusions of 2ml/kg, one the night before surgery and one the day after surgery |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmegavenAlso: purified fish oil, omega-3 fatty acids, eicosapentaenoicacid (EPA), docosahexaenoicacid (DHA)2 infusions, 2 ml/kg, one the night before operation and one the day after operation | Drug | Omegaven |
| PlaceboAlso: NaCl 0,9%, Natriumchloride 0,9%, glass container NaCl 0,9% Fresenius Kabi2 infusions, 2 ml/kg, one the night before operation and one the day after operation | Drug | Placebo |
Primary outcome
Change in ex vivo production of pro-inflammatory cytokine IL-6 in LPS stimulated whole blood
Time frame: baseline, day of surgery, postoperative day 1,2 and 4
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.
3 secondary outcomes
Change in ex vivo production of TNF-α and IL-10 in LPS stimulated whole blood
Time frame: baseline, day of surgery, postoperative day 1, 2 and 4
Change in erythrocyte function
Time frame: baseline, day of surgery, postoperative day 1, 2 and 4
Change in in vivo systemic inflammatory response parameters
Time frame: baseline, day of surgery, postoperative day 1, 2 and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Derived from this study: PubMed 31826232Bakker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A.P.J. Houdijk, Dr. principal investigator
Medical Center of Alkmaar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omegaven in people with Colon Cancer, run by Medical Center Alkmaar at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ex vivo production of pro-inflammatory cytokine IL-6 in LPS stimulated whole blood (time frame: baseline, day of surgery, postoperative day 1,2 and 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02231203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.