Adenomatous PolypsPhase 2/3NCT00432913
Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa
A Phase 2/3 study testing Eicosapentaenoic Acid (EPA), Endoscopy and Biopsies taken in people with Adenomatous Polyps, run by S.L.A. Pharma AG at 2 sites in 2 countries.
Trial summary
The purpose of this study is to determine the effect of two doses purified EPA (an omega-3 fatty acid), on apoptosis (natural cell death) and cell proliferation (formation of new cells) in the lining of the colon for patients with a history of colonic polyps. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenomatous Polyps
- What is being tested?
- Eicosapentaenoic Acid (EPA), Endoscopy and Biopsies taken
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2006to Jun 2008
- Phase
- Phase 2/3
- 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
- Males or females aged over 18
- Patients of child-bearing potential must demonstrate a negative pregnancy test at screening, and should use a reliable form of contraception during the trial and for 1 month afterwards, e.g:
- Oral contraceptive + condom
- Intra-uterine device (IUD)+ condom
- Diaphragm with spermicide + condom
- Male partners of women of child bearing potential should use a reliable form of contraception during the trial and for 1 month afterwards, e.g:
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- Oral contraceptive + condom
- Intra-uterine device (IUD)+ condom
- Diaphragm with spermicide + condom
- Patients must have a known history of colorectal adenomata and be under clinical follow-up for these, or be found to have one or more of these at the time of colonoscopy
- Patients must have provided written informed consent to participate
Who cannot join
- Patients who are allergic to fish
- Patients who have diabetes mellitus
- Patients who are pregnant or breast-feeding
- Patients taking aspirin or other non-steroidal anti-inflammatory drugs on a regular basis
- Patients who have aspirin-sensitive asthma
- Patients suffering from haemorrhagic disorders
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- Patients who are taking warfarin or other anticoagulants
- Patients who have significant abnormalities on their screening blood tests
- Patients taking lipid lowering medication
- Patients with known inflammatory bowel disease (IBD), or previously unknown IBD until discovered at the time of their colonoscopy
- Patients with gastrointestinal malabsorptive disease
- Patients belonging to a known polyposis syndrome (e.g. FAP, HNPCC)
- Patients with a previous colonic resection for colorectal cancer
- Patients who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study
- Patients who are deemed mentally incompetent, or have a history of anorexia nervosa or bulimia
- Patients with a history of alcohol or drug abuse, including laxative abuse
- Patients considered by their physician unlikely to be able to comply with the protocol.
- Patients who have taken part in an experimental drug study in the preceding 2 months.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
St. George's Hospital Medical School
London, SW17 0RE
About this study
Official title: The Effect of Two Dose Levels of Eicosapentaenoic Acid (EPA) on Apoptosis and Cell Proliferation in the Colonic Mucosa of Patients With a History of Colonic Polyps.
The purpose of this study is to determine the effect of two doses purified EPA (an omega-3 fatty acid), on apoptosis (natural cell death) and cell proliferation (formation of new cells) in the lining of the colon for patients with a history of colonic polyps.
Read the detailed description
Colorectal cancer is generally accepted to develop from changes within colonic adenomatous polyps. More than 90% of new large bowel cancers arise sporadically. The molecular events leading to the development of colorectal cancer from polyps are characterised by an imbalance in cell proliferation (formation of new cells) and apoptosis (natural cell death) from changes in the genes involved in normal colon cells.
Recent work at St George's Hospital Medical School, London, has shown significant beneficial effects on cell proliferation and apoptosis rates in the lining of the colon in subjects with a history of colonic adenomas using a highly purified, free-fatty acid form of eicosapentaenoic acid (EPA).
Comparator(s): 2g EPA per day for 6 months and 1g EPA per day for 6 months will be compared against placebo for 6 months.
- Conditions
- Adenomatous Polyps
- Being tested
- Eicosapentaenoic Acid (EPA), Endoscopy, Biopsies taken, Clinical chemistry, Haematology
- Keywords
- Eicosapentaenoic acid, EPA, EPA 99%, Fatty acid, omega-3, apoptosis, cell proliferation, colonic mucosa, polyps, adenomatous polyps, endoscopy, PUFA
- Medical subject headings
- Adenomatous Polyps, Hyperplasia, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eicosapentaenoic Acid (EPA)Drug
Also called ALFA
Either 2 x 500mg EPA capsules in the morning and evening (2g per day EPA) or 1 x 500mg EPA and 1 x placebo in the morning and evening (1g per day EPA)
EndoscopyProcedure or surgery
Also called Colonoscopy, Flexible sigmoidoscopy
At baseline, month 3 and month 6.
Biopsies takenProcedure or surgery
9 biopsies taken for measurement of apoptosis (3 biopsies), cell proliferation (3 biopsies) and fatty acid levels (3 biopsies) at baseline, month 3 and month 6.
Clinical chemistryProcedure or surgery
Full blood count at baseline, month 3 and month 6.
HaematologyProcedure or surgery
Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.
Physical examinationProcedure or surgery
Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.
Vital signsProcedure or surgery
Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.
Urine pregnancy testProcedure or surgery
For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.
Completion of patient diary cardProcedure or surgery
Subjects are requested to complete when study medication is taken and in any new or unusual symptoms are experienced on a daily basis for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 1g EPA per day | Active comparator | Not described Receives: Drug: Eicosapentaenoic Acid (EPA); Procedure: Endoscopy; Procedure: Biopsies taken; Procedure: Clinical chemistry; Procedure: Haematology; Procedure: Physical examination; Procedure: Vital signs; Procedure: Urine pregnancy test; Procedure: Completion of patient diary card |
| 2g EPA per day | Active comparator | Not described Receives: Drug: Eicosapentaenoic Acid (EPA); Procedure: Endoscopy; Procedure: Biopsies taken; Procedure: Clinical chemistry; Procedure: Haematology; Procedure: Physical examination; Procedure: Vital signs; Procedure: Urine pregnancy test; Procedure: Completion of patient diary card |
| Placebo | Placebo comparator | Not described Receives: Procedure: Endoscopy; Procedure: Biopsies taken; Procedure: Clinical chemistry; Procedure: Haematology; Procedure: Physical examination; Procedure: Vital signs; Procedure: Urine pregnancy test; Procedure: Completion of patient diary card |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure levels of apoptosis in the normal colonic mucosa in subjects with a history of colonic adenomas, before and after treatment with EPA 99%.
Measured: 3 months and 6 months
To measure levels of cell proliferation in the normal colonic mucosa in subjects with a history of colonic adenomas, before and after treatment with EPA 99%.
Measured: 3 months and 6 months
Secondary outcomes (2)
To measure the tissue content of EPA in the colonic mucosa before, during and after treatment with EPA.
Measured: 3 months and 6 months
To determine the safety and tolerability of EPA.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startOct 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenomatous PolypsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.L.A. Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nicholas J West, MB BS FRCS, Principal investigator, St. George's Hospital Medical School, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432913
- Sponsor's protocol ID
- EPA/POL/02
- Status last verified
- Oct 2008
- First submitted
- 7 Feb 2007
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Dose Levels of Eicosapentaenoic Acid (EPA) on Apoptosis and Cell Proliferation in the Colonic Mucosa of Patients With a History of Colonic Polyps.
- ClinicalTrials.gov ID
- NCT00432913
- Acronym / sponsor ID
- EPA/POL/02
- Conditions
- Adenomatous Polyps
- Keywords
- Eicosapentaenoic acid, EPA, EPA 99%, Fatty acid, omega-3, apoptosis, cell proliferation, colonic mucosa
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- S.L.A. Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 8 Feb 2007 (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.
The purpose of this study is to determine the effect of two doses purified EPA (an omega-3 fatty acid), on apoptosis (natural cell death) and cell proliferation (formation of new cells) in the lining of the colon for patients with a history of colonic polyps.
Detailed description
Colorectal cancer is generally accepted to develop from changes within colonic adenomatous polyps. More than 90% of new large bowel cancers arise sporadically. The molecular events leading to the development of colorectal cancer from polyps are characterised by an imbalance in cell proliferation (formation of new cells) and apoptosis (natural cell death) from changes in the genes involved in normal colon cells.
Recent work at St George's Hospital Medical School, London, has shown significant beneficial effects on cell proliferation and apoptosis rates in the lining of the colon in subjects with a history of colonic adenomas using a highly purified, free-fatty acid form of eicosapentaenoic acid (EPA).
Comparator(s): 2g EPA per day for 6 months and 1g EPA per day for 6 months will be compared against placebo for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1g EPA per day | Active comparator | Drug: Eicosapentaenoic Acid (EPA), Procedure: Endoscopy, Procedure: Biopsies taken, Procedure: Clinical chemistry, Procedure: Haematology, Procedure: Physical examination, Procedure: Vital signs, Procedure: Urine pregnancy test, Procedure: Completion of patient diary card |
| 2g EPA per day | Active comparator | Drug: Eicosapentaenoic Acid (EPA), Procedure: Endoscopy, Procedure: Biopsies taken, Procedure: Clinical chemistry, Procedure: Haematology, Procedure: Physical examination, Procedure: Vital signs, Procedure: Urine pregnancy test, Procedure: Completion of patient diary card |
| Placebo | Placebo comparator | Procedure: Endoscopy, Procedure: Biopsies taken, Procedure: Clinical chemistry, Procedure: Haematology, Procedure: Physical examination, Procedure: Vital signs, Procedure: Urine pregnancy test, Procedure: Completion of patient diary card |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males or females aged over 18
- Patients of child-bearing potential must demonstrate a negative pregnancy test at screening, and should use a reliable form of contraception during the trial and for 1 month afterwards, e.g:
- Oral contraceptive + condom
- Intra-uterine device (IUD)+ condom
- Diaphragm with spermicide + condom
Key exclusion criteria (18 listed)
- Patients who are allergic to fish
- Patients who have diabetes mellitus
- Patients who are pregnant or breast-feeding
- Patients taking aspirin or other non-steroidal anti-inflammatory drugs on a regular basis
- Patients who have aspirin-sensitive asthma
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 (EPA)Also: ALFAEither 2 x 500mg EPA capsules in the morning and evening (2g per day EPA) or 1 x 500mg EPA and 1 x placebo in the morning and evening (1g per day EPA) | Drug | 1g EPA per day, 2g EPA per day |
| EndoscopyAlso: Colonoscopy, Flexible sigmoidoscopyAt baseline, month 3 and month 6. | Procedure or surgery | 1g EPA per day, 2g EPA per day, Placebo |
| Biopsies taken9 biopsies taken for measurement of apoptosis (3 biopsies), cell proliferation (3 biopsies) and fatty acid levels (3 biopsies) at baseline, month 3 and month 6. | Procedure or surgery | 1g EPA per day, 2g EPA per day, Placebo |
| Clinical chemistryFull blood count at baseline, month 3 and month 6. | Procedure or surgery | 1g EPA per day, 2g EPA per day, Placebo |
| HaematologyUrea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6. | Procedure or surgery | 1g EPA per day, 2g EPA per day, Placebo |
| Physical examinationIncluding cardio-respiratory and abdominal examination at baseline, month 3 and month 6. | Procedure or surgery | 1g EPA per day, 2g EPA per day, Placebo |
| Vital signsHeight, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6. | Procedure or surgery | 1g EPA per day, 2g EPA per day, Placebo |
| Urine pregnancy testFor subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6. | Procedure or surgery | 1g EPA per day, 2g EPA per day, Placebo |
| Completion of patient diary cardSubjects are requested to complete when study medication is taken and in any new or unusual symptoms are experienced on a daily basis for 6 months. | Procedure or surgery | 1g EPA per day, 2g EPA per day, Placebo |
Primary outcome
To measure levels of apoptosis in the normal colonic mucosa in subjects with a history of colonic adenomas, before and after treatment with EPA 99%.
Time frame: 3 months and 6 months
To measure levels of cell proliferation in the normal colonic mucosa in subjects with a history of colonic adenomas, before and after treatment with EPA 99%.
Time frame: 3 months and 6 months
2 secondary outcomes
To measure the tissue content of EPA in the colonic mucosa before, during and after treatment with EPA.
Time frame: 3 months and 6 months
To determine the safety and tolerability of EPA.
Time frame: 3 months and 6 months
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 17 Oct 2008.
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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.
Nicholas J West, MB BS FRCS principal investigator
St. George's Hospital Medical School, London
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Eicosapentaenoic Acid (EPA), Endoscopy and Biopsies taken in people with Adenomatous Polyps, run by S.L.A. Pharma AG at 2 sites in 2 countries.
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 11 inclusion and 18 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 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To measure levels of apoptosis in the normal colonic mucosa in subjects with a history of colonic adenomas, before and after treatment with EPA 99%. (time frame: 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2008.