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: 7280313
• 负责人: WILLIAM W WONG
• 金额: $ 7.5万
• 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 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7280313
• 关键词: Accounting; Address; Adult; Age; Agonist; Area; Blinded; Blood; Cancer Etiology; Cancer Research Center of Hawaii; Cessation of life; Competitive Binding; Computer Assisted; Consumption; Cross-Sectional Studies; Data; Diet Modification; Dietary Fats; Disease; Dose; Double-Blind Method; Estrogen Antagonists; Estrogen Receptors; Estrogens; Exposure to; Film; Follow-Up Studies; Genetic Determinism; Goals; Gonadal Steroid Hormones; Gonadotropin Hormone Releasing Hormone; High Risk Woman; Hormonal; Hormone replacement therapy; Incidence; Intervention; Intervention Trial; Investigation; Isoflavones; Lead; Life; Linear Models; Mammary Gland Parenchyma; Mammographic Density; Mammography; Mass Spectrum Analysis; Measures; Menopause; Methods; Numbers; Osteoporosis prevention; Ovarian Ablation; Participant; Pharmaceutical Preparations; Phytoestrogens; Placebo Control; Placebos; Population; Postmenopause; Premenopause; Preventive; Progesterone; Property; Quality Control; Randomized; Randomized Controlled Clinical Trials; Reader; Reading; Role; Safety; Sampling; Scanning; Screening procedure; Singapore; Site; Soy Foods; Structure; Supplementation; Tamoxifen; Time; Trifolium pratense; United States; Woman; aged; base; breast density; cancer risk; day; density; experience; follow-up; malignant breast neoplasm; placebo controlled study; reproductive; size; soy; soy protein isolate

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）：在美国，每年每10万名妇女中有26人死于乳腺癌，发病率的上升是所有年龄段妇女的一个严重问题。含有高浓度异黄酮的大豆食品可能预防乳腺癌，但异黄酮对乳腺癌的潜在预防作用以及对高危妇女使用异黄酮的安全性尚不清楚。乳房x线摄影密度已被证明是乳腺癌风险的极好标志。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。该项目的目的是通过收集406名绝经后妇女的乳房x线照片来确定异黄酮补充与乳房x线照片密度之间的关系，这些妇女参加了一项为期2年的多地点、随机、双盲和安慰剂对照研究，即大豆预防骨质疏松症（OPUS）研究。在OPUS研究中，这些女性是随机的，1/3的女性接受80毫克/天的大豆苷元异黄酮，1/3接受120毫克/天的大豆苷元异黄酮，剩下的1/3接受安慰剂，为期2年。在基线和治疗12个月和24个月后，通过灵敏的四联质谱测定乳房x线筛查和血液中异黄酮及其代谢物的浓度。在夏威夷癌症研究中心使用柯达LS85胶片数字化仪扫描乳房x光片后，将使用计算机辅助定量方法评估乳房密度。读者将不知道受试者的分组分配和乳房x光检查的时间顺序。随机抽取影片样本一式两份以进行质量控制。统计分析将采用一般线性模型比较各治疗组的乳房x线检查措施，同时考虑重复措施。该项目将根据从最大的、接触异黄酮最多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异黄酮与乳房x线照相术密度之间的关系。随着美国大豆消费量创下历史新高，拟议的项目将为公众提供急需的关于大豆异黄酮补充剂对乳腺癌的安全性的科学数据。