1. The beta-carotene and retinol efficacy trial (CARET) for chemoprevention of lung cancer in high risk populations: smokers and asbestos-exposed workers.
- Author
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Omenn, G S, Goodman, G, Thornquist, M, Grizzle, J, Rosenstock, L, Barnhart, S, Balmes, J, Cherniack, M G, Cullen, M R, and Glass, A
- Subjects
Aged ,Anticarcinogenic Agents: therapeutic use ,Asbestos: adverse effects ,Carotenoids: adverse effects ,therapeutic use ,Female ,Follow-Up Studies ,Humans ,Lung Neoplasms: epidemiology ,etiology ,prevention & control ,Male ,Middle Aged ,Occupational Exposure ,Pilot Projects ,Risk Factors ,Smoking: adverse effects ,United States ,Vitamin A: adverse effects ,analogs & derivatives ,therapeutic use ,beta Carotene - Abstract
CARET is a multicenter, two-armed, double-masked randomized chemoprevention trial in Seattle, Portland, San Francisco, Baltimore, Connecticut, and Irvine, to test whether oral administration of beta-carotene (30 mg/day) plus retinyl palmitate (25,000 IU/day) can decrease the incidence of lung cancer in high risk populations, namely, heavy smokers and asbestos-exposed workers. The intervention combines the antioxidant action of beta-carotene and the tumor suppressor mechanism of vitamin A. As of April 30, 1993, CARET had randomized 1,845 participants in the 1985-1988 pilot phase plus 13,260 "efficacy" participants since 1989; of these, 4,000 are asbestos-exposed males and 11,105 are smokers and former smokers (44% female). Accrual is complete everywhere except Irvine, which was the last center added (1991), and the safety profile of the regimen to date has been excellent. With 14,420 smokers, 4,010 asbestos-exposed participants, and 114,100 person-years through February 1998, we expect CARET to be capable of detecting a 23% reduction in lung cancer incidence in the two populations combined and 27, 49, 32, and 35% reductions in the smokers, female smokers, male smokers, and asbestos-exposed subgroups, respectively. CARET is highly complementary to the alpha-tocopherol-beta-carotene study in Finland and the Harvard Physicians Health Study (beta-carotene alone) in the National Cancer Institute portfolio of major cancer chemoprevention trials.
- Published
- 1994