Colorectal CancerPhase 2EMTNCT01070355
Eicosapentaenoic Acid (EPA) for Treatment of Colorectal Cancer Liver Metastases
A Phase 2 study testing Eicosapentaenoic acid free fatty acid in people with Colorectal Cancer, run by University of Leeds at 1 site in United Kingdom.
Trial summary
Eicosapentaenoic acid (EPA) is a naturally occuring omega-3 polyunsaturated fatty acid found in oily fish. EPA has anti-colorectal (bowel) cancer activity in experimental models. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Eicosapentaenoic acid free fatty acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2010to Oct 2011
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Either sex
- Liver resection deemed clinically appropriate for management of metastatic colorectal cancer
- Duration between decision to perform liver resection and surgery greater than 2 weeks
- Ability to give written informed consent and follow study protocol
- Telephone contact possible
Who cannot join
- Neo-adjuvant chemotherapy for colorectal cancer (CRC) liver metastasis
- Chemotherapy for any cancer in the previous 3 months
- Known bleeding diathesis or anticoagulation therapy
- Fish or seafood allergy
- Use of fish oil supplements (eg. cod liver oil) and unwilling to stop for the duration of the study
- Pregnancy
Show all 9Show fewer
- Non-aspirin non-steroidal anti-inflammatory (NSAID) or corticosteroid use
- Renal impairment (serum creatinine >150)
- Active inflammatory disease (e.g. Inflammatory Bowel Disease, Rheumatoid Arthritis).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Institute of Molecular Medicine, St James's University Hospital
Leeds, West Yorkshire, LS9 7TF
About this study
Official title: The Effects of Eicosapentaenoic Acid (EPA) on Biomarkers of Growth and Vascularity in Human Colorectal Cancer Liver Metastases (The EPA for Metastasis Trial)
Eicosapentaenoic acid (EPA) is a naturally occuring omega-3 polyunsaturated fatty acid found in oily fish. EPA has anti-colorectal (bowel) cancer activity in experimental models. This trial will test whether EPA reduces markers of tumour growth, and is safe and well tolerated,in patients with colorectal cancer liver metastases awaiting surgery.
Read the detailed description
A double-blind, randomised, placebo-controlled trial of eicosapentaenoic acid (EPA), in the free fatty acid form, 2g daily in patients who will undergo liver resection surgery for colorectal cancer liver metastases.
- Conditions
- Colorectal Cancer
- Being tested
- Eicosapentaenoic acid free fatty acid, Placebo
- Keywords
- Colorectal Neoplasms, Fish Oils, Fatty Acids, Omega-3, Eicosapentaenoic Acid, Liver Metastases, Randomised Controlled Trial
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eicosapentaenoic acid free fatty acidDrug
Also called ALFA
An enteric-coated preparation of 99% pure omega-3 polyunsaturated fatty acid (PUFA) eicosapentaenoic acid as the free fatty acid. 500mg capsules, 2 taken twice daily for 2-6 weeks before liver resection.
PlaceboDrug
2 capsules taken twice daily for 2-6 weeks before liver resection.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 capsules twice daily Receives: Drug: Placebo |
| Eicosapentaenoic acid free fatty acid | Active comparator | 2g daily (2 x 500mg capsules twice daily) Receives: Drug: Eicosapentaenoic acid free fatty acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Ki67 cancer cell proliferation index
Measured: at surgery 2-6 weeks after randomisation
Secondary outcomes (7)
Histological neo-CK18 cancer cell apoptosis index
Measured: at surgery 2-6 weeks after randomisation
Histological tumour CD31-positive cell microvessel density
Measured: at surgery 2-6 weeks after randomisation
Safety and tolerability of EPA treatment
Measured: Every 2 weeks whilst patient is taking study medication
Metastatic tissue and healthy liver tissue fatty acid composition and prostaglandin levels
Measured: at surgery 2-6 weeks after randomisation
Plasma markers of prostaglandin metabolism
Measured: 1. Baseline 2. after approx 4 weeks of study medication (immediately prior to surgery). 3. Six weeks after liver resection (no study medication)
Platelet aggregation
Measured: 1. Baseline 2. after approx 4 weeks of study medication (immediately prior to surgery). 3. Six weeks after liver resection (no study medication)
Urinary markers of prostaglandin metabolism
Measured: 1. Baseline 2. after 2 weeks of study medication 3. after approx 4 weeks of study medication (immediately prior to surgery). 4. Six weeks after liver resection (no study medication)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2011
- Study completionOct 2011
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 Colorectal 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Hull, University of Leeds
- Investigators
- Mark A Hull, PhD, FRCP, Principal investigator, Leeds Institute of Molecular Medicine, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070355
- Sponsor's protocol ID
- GA09/9094
- Other IDs
- 2009-015903-22, 2009
- Acronym
- EMT
- Status last verified
- Oct 2011
- First submitted
- 12 Feb 2010
- Last updated
- 21 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cockbain AJ, Volpato M, Race AD, Munarini A, Fazio C, Belluzzi A, Loadman PM, Toogood GJ, Hull MA. Anticolorectal cancer activity of the omega-3 polyunsaturated fatty acid eicosapentaenoic acid. Gut. 2014 Nov;63(11):1760-8. doi: 10.1136/gutjnl-2013-306445. Epub 2014 Jan 27.
PubMed 24470281
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Eicosapentaenoic Acid (EPA) on Biomarkers of Growth and Vascularity in Human Colorectal Cancer Liver Metastases (The EPA for Metastasis Trial)
- ClinicalTrials.gov ID
- NCT01070355
- Acronym / sponsor ID
- EMT / GA09/9094
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Neoplasms, Fish Oils, Fatty Acids, Omega-3, Eicosapentaenoic Acid, Liver Metastases, Randomised Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 18 Feb 2010 (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.
Eicosapentaenoic acid (EPA) is a naturally occuring omega-3 polyunsaturated fatty acid found in oily fish. EPA has anti-colorectal (bowel) cancer activity in experimental models. This trial will test whether EPA reduces markers of tumour growth, and is safe and well tolerated,in patients with colorectal cancer liver metastases awaiting surgery.
Detailed description
A double-blind, randomised, placebo-controlled trial of eicosapentaenoic acid (EPA), in the free fatty acid form, 2g daily in patients who will undergo liver resection surgery for colorectal cancer liver metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo2 capsules twice daily |
| Eicosapentaenoic acid free fatty acid | Active comparator | Drug: Eicosapentaenoic acid free fatty acid2g daily (2 x 500mg capsules twice daily) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years
- Either sex
- Liver resection deemed clinically appropriate for management of metastatic colorectal cancer
- Duration between decision to perform liver resection and surgery greater than 2 weeks
- Ability to give written informed consent and follow study protocol
Key exclusion criteria (9 listed)
- Neo-adjuvant chemotherapy for colorectal cancer (CRC) liver metastasis
- Chemotherapy for any cancer in the previous 3 months
- Known bleeding diathesis or anticoagulation therapy
- Fish or seafood allergy
- Use of fish oil supplements (eg. cod liver oil) and unwilling to stop for the duration of the study
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 |
|---|---|---|
| Eicosapentaenoic acid free fatty acidAlso: ALFAAn enteric-coated preparation of 99% pure omega-3 polyunsaturated fatty acid (PUFA) eicosapentaenoic acid as the free fatty acid. 500mg capsules, 2 taken twice daily for 2-6 weeks before liver resection. | Drug | Eicosapentaenoic acid free fatty acid |
| Placebo2 capsules taken twice daily for 2-6 weeks before liver resection. | Drug | Placebo |
Primary outcome
Histological Ki67 cancer cell proliferation index
Time frame: at surgery 2-6 weeks after randomisation
7 secondary outcomes
Histological neo-CK18 cancer cell apoptosis index
Time frame: at surgery 2-6 weeks after randomisation
Histological tumour CD31-positive cell microvessel density
Time frame: at surgery 2-6 weeks after randomisation
Safety and tolerability of EPA treatment
Time frame: Every 2 weeks whilst patient is taking study medication
Metastatic tissue and healthy liver tissue fatty acid composition and prostaglandin levels
Time frame: at surgery 2-6 weeks after randomisation
Plasma markers of prostaglandin metabolism
Time frame: 1. Baseline 2. after approx 4 weeks of study medication (immediately prior to surgery). 3. Six weeks after liver resection (no study medication)
Platelet aggregation
Time frame: 1. Baseline 2. after approx 4 weeks of study medication (immediately prior to surgery). 3. Six weeks after liver resection (no study medication)
Urinary markers of prostaglandin metabolism
Time frame: 1. Baseline 2. after 2 weeks of study medication 3. after approx 4 weeks of study medication (immediately prior to surgery). 4. Six weeks after liver resection (no study medication)
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 21 Oct 2011.
- Derived from this study: PubMed 24470281Cockbain AJ, Volpato M, Race AD, Munarini A, Fazio C, Belluzzi A, Loadman PM, Toogood GJ, Hull MA. Anticolorectal cancer activity of the omega-3 polyunsaturated fatty acid eicosapentaenoic acid. Gut. 2014 Nov;63(11):1760-8. doi: 10.1136/gutjnl-2013-306445. Epub 2014 Jan 27.
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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.
Mark A Hull, PhD, FRCP principal investigator
Leeds Institute of Molecular Medicine, University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eicosapentaenoic acid free fatty acid in people with Colorectal Cancer, run by University of Leeds at 1 site in United Kingdom.
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 6 inclusion and 9 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 21 Oct 2011. 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Histological Ki67 cancer cell proliferation index (time frame: at surgery 2-6 weeks after randomisation). 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 NCT01070355, 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 21 Oct 2011.