PHASE I PREVENTION TRIAL OF ACTIVIN TM GRAPE SEED EXTRACT AS AN AROMATASE INHIBI

ACTIVIN TM 葡萄籽提取物作为芳香酶抑制剂的 I 期预防试验

• 批准号: 7603877
• 负责人: MELANIE R PALOMARES
• 金额: $ 6.01万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603877
• 关键词: Activins; Adrenal Glands; Aromatase; Aromatase Inhibition; Aromatase Inhibitors; Biological Assay; Biological Availability; Blood; Breast Cancer Prevention; Chemoprevention; Computer Retrieval of Information on Scientific Projects Database; Contralateral; Dose; Estrogens; Funding; Grant; Human; Institution; Methods; Pharmacologic Substance; Phase; Placebo Control; Postmenopause; Prevention; Research; Research Personnel; Resources; Safety; Schedule; Serum; Source; Standards of Weights and Measures; Symptoms; Translations; United States National Institutes of Health; Week; Woman; bone metabolism; cancer risk; dietary supplements; grape seed extract; malignant breast neoplasm

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Decreased contralateral breast cancer (BC) seen with aromatase inhibitor therapy suggests they may be effective for BC prevention. Nutriceuticals are popular alternatives for women who prefer dietary supplements over standard pharmaceuticals. Our group demonstrated a previously unknown anti-aromatase effect with grape-seed extract (GSE). We propose translation to a human BC chemoprevention trial. Objectives: 1. to determine whether GSE significantly suppresses circulating estrogens in postmenopausal women at increased BC risk, 2. to gather preliminary dose information, 3. to determine bioavailability, and 4. to evaluate safety and tolerability in humans. Methods: Twenty-four subjects will be treated with GSE at four dose levels for a 12-week period, following a 2-week placebo control period. Blood will be drawn at scheduled intervals for serum estrogen, procyanidin concentration, and aromatase inhibition assays. Markers of bone metabolism and adrenal suppression will be checked pre and post GSE, and symptom logs will be followed.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 芳香酶抑制剂治疗对侧乳腺癌 (BC) 减少表明它们可能对预防 BC 有效。对于那些更喜欢膳食补充剂而不是标准药物的女性来说，营养品是流行的替代品。我们的团队证明了葡萄籽提取物 (GSE) 具有以前未知的抗芳香酶作用。我们建议将其转化为人类 BC 化学预防试验。 目标： 1. 确定 GSE 是否显着抑制 BC 风险增加的绝经后妇女的循环雌激素， 2. 收集初步剂量信息， 3. 测定生物利用度，以及 4. 评估人类的安全性和耐受性。 方法：24 名受试者将在 2 周安慰剂对照期后接受 4 种剂量水平的 GSE 治疗，为期 12 周。将按预定时间间隔抽血进行血清雌激素、原花青素浓度和芳香酶抑制测定。 GSE 前后将检查骨代谢和肾上腺抑制标志物，并跟踪症状日志。