Soy Isoflavone Supplementation and Mammographic Density in Postmenopausal Women

大豆异黄酮补充剂和绝经后妇女的乳房X光密度

• 批准号: 7116114
• 负责人: WILLIAM W WONG
• 金额: $ 8.95万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7116114
• 关键词: breast density; breast neoplasms; clinical research; density; estrogens; placebos

DESCRIPTION (provided by applicant): Breast cancer accounts for 26 annual deaths per 100,000 women in the United States and the rising incidence is a serious concern among women of all ages. Soy foods, which contain high concentrations of isoflavones, might protect against breast cancer, but the potential preventive benefit of isoflavones against breast cancer and the safety of administering isoflavones to high-risk women are not well understood. Mammographic density has been shown to be an excellent marker for breast cancer risk. Hormone replacement therapy, in particular progesterone, increases breast densities, whereas tamoxifen therapy decreases densities. The goal of the proposed project is to determine the relationship between isoflavone supplementation and mammographic densities using the mammograms collected from 406 postmenopausal women who participated in a 2-year multi-site, randomized, double-blind, and placebo-controlled study, the Osteoporosis Prevention Using Soy (OPUS) study. In the OPUS study, the women were randomized so that 1/3 of the women receive 80 mg/d of aglycone soy isoflavones, 1/3 receive 120 mg/d of aglycone soy isoflavones, and the remaining 1/3 receive a placebo for 2 years. Screening mammograms and blood concentrations of isoflavones and their metabolites measured by sensitive quadruple mass spectrometry were obtained at baseline and after 12 and 24 months of treatment. After scanning the mammograms films at the Cancer Research Center of Hawaii using a Kodak LS85 Film Digitizer, breast density will be assessed using a computer-assisted quantitative method. The reader will be blinded to the group assignment of the subjects and the time sequence of the mammograms. A random sample of films will be read in duplicate for quality control. The statistical analysis will apply general linear models to compare mammographic measures by treatment group, while considering the repeated measures. The project will provide critical information, based on data collected from the largest follow-up study with the highest isoflavone exposure, to document the relation between isoflavone supplementation and mammographic density in postmenopausal women. With the consumption of soy at record high in the United States, the proposed project will provide the much needed scientific data to the public on the safety of soy isoflavone supplementation against breast cancer.

描述（由申请人提供）：乳腺癌在美国每10万名妇女中每年死亡26人，发病率上升是所有年龄段妇女的严重问题。大豆食品含有高浓度的异黄酮，可能会预防乳腺癌，但异黄酮对乳腺癌的潜在预防作用以及对高危女性使用异黄酮的安全性尚不清楚。乳腺摄影密度已被证明是乳腺癌风险的一个很好的标志物。激素替代疗法，特别是黄体酮，增加乳房密度，而他莫昔芬治疗降低密度。该项目的目的是使用从406名绝经后妇女中收集的乳房X线照片确定补充维生素B2和乳房X线照片密度之间的关系，这些妇女参加了一项为期2年的多中心、随机、双盲和安慰剂对照研究，即使用大豆预防骨质疏松症（OPUS）研究。在OPUS研究中，女性被随机分组，1/3的女性接受80 mg/d的大豆苷元黄酮，1/3接受120 mg/d的大豆苷元黄酮，其余1/3接受安慰剂，持续2年。在基线和治疗12个月和24个月后，获得了筛查乳房X线照片和通过灵敏的四重质谱法测量的孕酮及其代谢物的血液浓度。在夏威夷癌症研究中心使用柯达LS 85胶片数字化仪扫描乳房X线照片后，将使用计算机辅助定量方法评估乳房密度。阅片人将对受试者的分组和乳房X线照片的时间顺序设盲。随机抽取的胶片样本将一式两份阅读，以进行质量控制。统计分析将采用一般线性模型按治疗组比较乳腺摄影测量值，同时考虑重复测量值。该项目将根据从最大规模的后续研究中收集的数据提供关键信息，以记录绝经后妇女补充维生素D与乳房X线摄影密度之间的关系。随着美国大豆消费量创历史新高，该项目将为公众提供关于大豆膳食补充剂预防乳腺癌安全性的急需科学数据。