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.
18 Years
N/A
Both
Adenomatous Polyps
Trial Information
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.
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.
Inclusion Criteria:
- 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:
- 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
Exclusion Criteria:
- 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
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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%.
Outcome Time Frame:
3 months and 6 months
Principal Investigator
Nicholas J West, MB BS FRCS
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. George's Hospital Medical School, London
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
EPA/POL/02
NCT ID:
NCT00432913
Start Date:
October 2006
Completion Date:
June 2008
Related Keywords:
- Adenomatous Polyps
- Eicosapentaenoic acid
- EPA
- EPA 99%
- Fatty acid
- omega-3
- apoptosis
- cell proliferation
- colonic mucosa
- polyps
- adenomatous polyps
- endoscopy
- PUFA
- Polyps
- Adenomatous Polyps
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