Spots Global Cancer Trial Database for Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa

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Trial Identification

Brief Title: Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa

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.

Study ID: NCT00432913

Conditions

Adenomatous Polyps

Interventions

Eicosapentaenoic Acid (EPA)

Completion of patient diary card

Study Description

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 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.