CALCIUM AND ASPIRIN PREVENTION TRIAL

Project: Research project

Project Details

Description

DESCRIPTION (Adapted from the investigator's abstract): Modification of
the carcinogenic process by dietary supplements and pharmacologic agents
is a major emphasis in colon cancer prevention research. Two sequential
studies are proposed to investigate the role of combined calcium and
aspirin supplementation in colon cancer chemoprevention. The two agents
are chosen because (a) extensive epidemiologic and laboratory data
support their chemopreventive potential, (b) their safety profile has
been well delineated in other health conditions in which they are of
benefit, (c) they may have complementary mechanisms of action, and (d)
the research team has considerable experience with these agents. Target
populations will be subjects with a prior history of sporadic
adenomatous polyps of the colon within 5 years of entry and no history
of previous malignancy. A preliminary Phase 2a trial is designed to
determine the minimum dose of aspirin which has relevant biologic
activity. A subsequent randomized, double-blind, placebo controlled
Phase 2b trial is designed to test the single and combined
chemopreventive effects of aspirin and calcium, given for 12 weeks. The
aspirin dose will be determined in the phase 2a trial, and the calcium
dose will be the previously demonstrated effective dose of 2000 mg/d.
The primary endpoints will be colonic mucosal prostaglandin E2 levels and
epithelial proliferation indices measured by PCNA methodology. The
investigators hypothesize that calcium and aspirin will have a
synergistic, risk reducing effect on the colonic mucosa in subjects with
a history of adenomatous polyps. The study will be performed in a
network of gastroenterologists with access to a large population of
adenomatous polyp patients and extensive experience in chemoprevention
trials. Data from the phase 2b study will serve to construct a phase 3
study on recurrent polyps.
StatusFinished
Effective start/end date9/21/958/31/01

ASJC

  • Medicine(all)