Mammographic Density and Soy Isoflavones

乳房X光密度和大豆异黄酮

基本信息

批准号：
7903686
负责人：
LEE-JANE W LU
金额：
$ 3.95万
依托单位：
UNIVERSITY OF TEXAS MED BR GALVESTON
依托单位国家：
美国
项目类别：
财政年份：
2003
资助国家：
美国
起止时间：
2003-09-15 至 2010-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7903686
关键词：
2-hydroxyestrone 3-Dimensional Adipose tissue Adverse effects Affect Age Amenorrhea Androstenedione Area Asians Aspirate substance Biological Markers Blinded Blood Blood Chemical Analysis Bone Density Breast Breast Cancer Early Detection Breast Cancer Prevention Breast Cancer Risk Factor Cells Characteristics Chemopreventive Agent Chronic Clinical Research Computer-Assisted Image Analysis Consumption Country Cytology Data Dependence Development Diet Diet Habits Dietary Factors Dietary Intervention Doctor of Philosophy Dose Double-Blind Method Endometrial Endometrium Epithelial Estrogens Estrone-Sulfate Excretory function Exposure to Future Hemorrhage Histology Hormones Hydroxyestrones Hyperplasia Image Incidence Individual Ingestion Intervention Isoflavones Lead Liquid substance Magnetic Resonance Imaging Mammary Gland Parenchyma Mammographic Density Mammography Masks Mass in breast Measurement Measures Menarche Menopause Menstrual cycle Monitor Nipples Nutrient Outcome Ovarian Ovarian Steroid Hormone Ovarian hormone Patients Period Analysis Physiological Placebo Control Placebos Population Postmenopause Pregnancy Premenopause Preventive Intervention Progesterone Randomized Recruitment Activity Regression Analysis Reproductive History Research Research Personnel Risk Risk Factors Risk Marker Risk Reduction Safety Sampling Screening procedure Serum Statistical Methods Statistical Models Steroids Surrogate Markers Testing Time Tissues Treatment Efficacy Upper arm Urine Vagina Woman breast density cancer risk feeding high risk improved interest keratinization malignant breast neoplasm nipple aspirate fluid novel pill programs reproductive soy soy protein isolate two-dimensional urinary

项目摘要

DESCRIPTION (provided by applicant): Populations consuming high levels of soy, as in many Asian countries, have lower levels of ovarian hormones, lower rates of breast cancer, and reduced mammographic density than populations consuming typical Western diets. These observations may in part be explained by our clinical studies that found ovarian hormone levels of premenopausal women to be lowest while they were consuming a diet that provided 15% energy from soymilk containing weakly estrogenic isoflavones. No adverse effects were observed. Further questions are whether isoflavones are the critical components influencing breast cancer risk and whether they do so by affecting other reversible risk markers for breast cancer, such as breast density. Women with dense breasts have a 4-6 fold excess risk of developing breast cancer. Moreover, greater breast density makes it more difficult to detect early breast cancer by mammography. To test the hypothesis that consumption of soy isoflavones reduces breast density, we propose a randomized, double blind study, with two arms, and 100 premenopausal women in each arm. Women with >50% of dense breast tissue will be recruited and randomly allocated to take soy isoflavone pills (treatment) or placebo pills containing no isoflavones (control) for 2 years. The daily dose will be 150 mg of total isoflavones. Women will provide blood and urine samples before and during the supplement intervention period for the analyses of ovarian hormones and isoflavones. At baseline and after the intervention period, subjects will be examined for breast density by mammography and magnetic resonance imaging. The efficacy of the intervention will be determined by comparing mean changes of dense breast tissue over the 2-year intervention period in the two groups with adjustment for baseline values and individual patient characteristics of interest. We hypothesize that 1 to 2 years of a soy isoflavone supplement in premenopausal women will reduce the effects of endogenous estrogens and reduce progesterone levels further, which will explain a corresponding decrease in breast density. Our research results will have significant implications for breast cancer risk reduction. Reducing breast density can be expected to reduce the volume of target tissue at risk for breast cancer development and will improve the sensitivity of mammography for screening. The study may lead to a novel, non-invasive and economical approach to breast cancer prevention.

描述（由申请人提供）：与许多食用典型西方饮食的种群相比，卵巢荷尔蒙的水平较低，卵巢荷尔蒙的水平较低，乳腺癌的速度较低，乳腺癌降低和乳房X线摄影密度降低。这些观察结果可能部分是通过我们的临床研究来解释的，我们的临床研究发现卵巢激素水平的绝经前妇女水平是最低的，而她们食用饮食，该饮食从含有弱雌激素异黄酮的豆浆中提供15％的能量。未观察到不利影响。另一个问题是异黄酮是否是影响乳腺癌风险的关键组成部分，以及它们是否通过影响乳腺癌（例如乳腺癌）的其他可逆风险标志物而造成的关键组成部分。乳房茂密的妇女患乳腺癌的多余风险为4-6倍。此外，更高的乳房密度使通过乳房X线摄影检测早期乳腺癌变得更加困难。为了检验以下假设：食用大豆异黄酮可以降低乳房密度，我们提出了一项随机的双盲研究，每个手臂中有两个手臂和100个绝经前女性。将招募> 50％的密集乳腺组织的妇女将被招募并随机分配以服用大豆异黄酮药（治疗）或安慰剂药物，其中含有无异黄酮（对照）2年。每日剂量为150毫克的异黄酮。妇女将在补充干预期之前和期间提供血液和尿液样本，以分析卵巢激素和异黄酮。在基线和干预期之后，将通过乳房X线摄影和磁共振成像检查受试者的乳房密度。干预措施的功效将通过比较两组在两组中的密集乳房组织的平均变化以及对基线值和个人感兴趣的个人特征的调整来确定。我们假设在绝经前妇女中1至2年的大豆异黄酮补充剂将降低内源性雌激素的作用，并进一步降低孕酮水平，这将解释相应的乳房密度降低。我们的研究结果将对乳腺癌的降低具有重要意义。可以预期降低乳房密度会减少乳腺癌发育风险的靶组织量，并提高乳房X线摄影的筛查敏感性。这项研究可能导致一种新型，无创和经济的预防乳腺癌方法。