Clinical Trial: Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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.
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 of the colon for patients with a history of colonic polyps.
Detailed Summary:
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.
Sponsor: S.L.A. Pharma AG
Current 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 ]
Original Primary Outcome: To measure levels of apoptosis and proliferation levels in patients with a history of colonic adenomas, before and after treatment with EPA.
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome:
- To measure the uptake of EPA into the colonic mucosa before and after treatment with EPA.
- To determine the safety and tolerability of EPA.
Information By: S.L.A. Pharma AG
Dates:
Date Received: February 7, 2007
Date Started: October 2006
Date Completion:
Last Updated: October 16, 2008
Last Verified: October 2008
