Status:
COMPLETED
Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa
Lead Sponsor:
S.L.A. Pharma AG
Conditions:
Adenomatous Polyps
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ...
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 deve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00432913
Start Date
October 1 2006
End Date
June 1 2008
Last Update
October 17 2008
Active Locations (2)
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1
S. Orsola Hospital
Bologna, Italy, 40138
2
St. George's Hospital Medical School
London, United Kingdom, SW17 0RE