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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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%.
3 months and 6 months
Nicholas J West, MB BS FRCS
St. George's Hospital Medical School, London
United Kingdom: Medicines and Healthcare Products Regulatory Agency