S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000
Summary
RATIONALE: Aging may affect a person's vision. Vitamin E and/or selenium may help prevent cataracts or age-related macular degeneration in men receiving these drugs as part of a clinical trial for the prevention of prostate cancer. PURPOSE: This clinical trial is studying vitamin E and/or selenium to see how well they work in preventing cataract and age-related macular degeneration in men enrolled on SELECT (SWOG-S0000).
Timeline
- Start
- 2004-07
- Primary completion
- 2017-11
- Completion
- 2018-05
Outcome
Missed primary endpoint
registry analysis (superiority test); AMD: Selenium Active vs AMD: Selenium Placebo; p = 0.52; Cox Proportional Hazard 0.75 (95% CI 0.32 to 1.79); Regression, Cox NCT00784225 ↗
registry analysis (superiority test); AMD: Vitamin E Active vs AMD: Vitamin E Placebo; p = 0.51; Cox Proportional Hazard 0.75 (95% CI 0.31 to 1.77); Regression, Cox NCT00784225 ↗
registry analysis (superiority test); Cataract: Selenium Active vs Cataract: Selenium Placebo; p = 0.37; Cox Proportional Hazard 0.91 (95% CI 0.75 to 1.11); Regression, Cox NCT00784225 ↗
registry analysis (superiority test); Cataract: Vitamin E Active vs Cataract: Vitamin E Placebo; p = 0.81; Cox Proportional Hazard 1.02 (95% CI 0.84 to 1.25); Regression, Cox NCT00784225 ↗
Publications
- Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.
- Christen WG, Glynn RJ, Gaziano JM, Darke AK, Crowley JJ, Goodman PJ, Lippman SM, Lad TE, Bearden JD, Goodman GE, Minasian LM, Thompson IM Jr, Blanke CD, Klein EA. Age-related cataract in men in the selenium and vitamin e cancer prevention trial eye endpoints study: a randomized clinical trial. JAMA Ophthalmol. 2015 Jan;133(1):17-24. doi: 10.1001/jamaophthalmol.2014.3478.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Selenium | Other / unclassified | 200 ug | — |
| Subject | Vitamin E | Other / unclassified | 400 iu | Oral |