NCT00432913

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

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.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: S.L.A. Pharma AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenomatous Polyps

Interventions

Type	Name	Description
DRUG	Eicosapentaenoic Acid (EPA)	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)
PROCEDURE	Endoscopy	At baseline, month 3 and month 6.
PROCEDURE	Biopsies taken	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.
PROCEDURE	Clinical chemistry	Full blood count at baseline, month 3 and month 6.
PROCEDURE	Haematology	Urea and electrolytes, liver function tests, clotting profile and CRP at baseline, month 3 and month 6.
PROCEDURE	Physical examination	Including cardio-respiratory and abdominal examination at baseline, month 3 and month 6.
PROCEDURE	Vital signs	Height, weight, heart rate, blood pressure and temperature at baseline, month 3 and month 6.
PROCEDURE	Urine pregnancy test	For subjects of child-bearing potential, urine pregnancy test at baseline, month 3 and month 6.
PROCEDURE	Completion of patient diary card	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.

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-02-08
• Last updated: 2008-10-17

Locations

2 sites across 2 countries: Italy, United Kingdom