This application seeks 5 years of funding to include a study of age-related macular degeneration (AMD) and cataract in the ongoing Selenium and Vitamin E Cancer Prevention Trial (SELECT). SELECT is a randomized double-blind, placebo-controlled, 2x2 factorial trial of selenium and vitamin E in the primary prevention of prostate cancer. The target sample is 32,400 healthy males, age 55 years and older for white men, and age 50 and older for African-American men. Study duration is planned to be 12 years with a 5-year uniform accrual period, and a minimum of 7 and maximum of 12 years of intervention depending on the time of randomization. This ongoing trial offers a unique opportunity to examine AMD and cataract in a large trial of antioxidants at a fraction of the cost of a separate trial. The proposed eye study will employ established procedures to collect medical record data to confirm reports of AMD and cataract made by SELECT study participants at bi-annual clinic visits. The data collected in this study will complement the data collected in the Age-Related Eye Disease Study (AREDS) by providing important information on the individual effects of vitamin E and selenium in AMD and cataract including, but not limited to, the earlier stages of disease development. Together with the findings in AREDS and in other ongoing trials in men and women, this study will help determine the balance of benefits and risks of antioxidant vitamins in the prevention of age-related eye disease in individuals at various levels of risk, and thus enable more specific clinical recommendations for eye health care providers and patients.
| Goodman, Phyllis J; Tangen, Catherine M; Darke, Amy K et al. (2016) Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials 17:400 |
| Christen, William G; Glynn, Robert J; Gaziano, J Michael et al. (2015) Age-related cataract in men in the selenium and vitamin e cancer prevention trial eye endpoints study: a randomized clinical trial. JAMA Ophthalmol 133:17-24 |
| Minasian, Lori M; Tangen, Catherine M; Wickerham, D Lawrence (2015) Ongoing Use of Data and Specimens From National Cancer Institute-Sponsored Cancer Prevention Clinical Trials in the Community Clinical Oncology Program. Semin Oncol 42:748-63 |
| Coltman Jr, Charles A; Southwest Oncology Group (2008) The Southwest Oncology Group: progress in cancer research. Semin Oncol 35:545-52 |
