Evidence supports the potential role of beta-carotene in cancer prevention. Basic research has demonstrated that beta-carotene can trap organic free radicals and/or deactivate excited oxygen molecules which may have an anticancer effect by preventing tissue damage. Although observational epidemiologic studies are not entirely consistent, many show an inverse association between dietary intake or blood levels of beta-carotene and subsequent cancer risk. Two large-scale randomized trials of beta-carotene have been completed. A Finnish trial demonstrated no benefit of beta-carotene among middle-aged male smokers, with those assigned to this supplement in fact experiencing an increased risk of lung cancer. However, because of the long latency period for cancer, which may be a decade or more, the six-year duration of treatment in this trial may have been inadequate to detect an anticancer effect. A Chinese trial demonstrated a modest reduction in cancer mortality from a combined regimen of beta-carotene, vitamin E, and selenium. The effect of the individual agents could not be assessed, and because the trial was carried out among a nutritionally deficient population, its results may not have direct relevance to well-nourished individuals. Several additional large-scale trials of beta-carotene are ongoing. The Physicians' Health Study, which is testing beta-carotene among 22,071 US male physicians, will have an average duration of treatment of 12.5 years at its scheduled termination in late 1995. Data in women will be available from the Women's Health Study, which began in 1992 and will randomize approximately 40,000 US female health professionals. The results from these and other ongoing trials are necessary to determine conclusively whether beta-carotene reduces risks of cancer. (C) 1995 Wiley-Liss, Inc.