CLINICAL TRIAL: PHASE I PREVENTION TRIAL OF ACTIVIN TM GRAPE SEED EXTRACT AS AN

临床试验：ACTIVIN TM 葡萄籽提取物作为抗病毒药物的 I 期预防试验

• 批准号: 7982060
• 负责人: MELANIE R PALOMARES
• 金额: $ 2.78万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7982060
• 关键词: Activins; Adrenal Glands; Aromatase; Aromatase Inhibition; Aromatase Inhibitors; Biological Assay; Biological Availability; Blood; Breast Cancer Prevention; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Contralateral; Dose; Estrogens; Funding; Grant; Human; Institution; Methods; Pharmacologic Substance; Phase I Clinical Trials; Placebo Control; Postmenopause; Prevention; Research; Research Personnel; Resources; Safety; Schedule; Serum; Source; Symptoms; Translations; United States National Institutes of Health; Woman; bone metabolism; cancer chemoprevention; 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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 芳香化酶抑制剂治疗对侧乳腺癌（BC）的减少表明它们可能对BC预防有效。营养保健品是那些喜欢膳食补充剂而不是标准药物的女性的流行选择。我们的小组证明了葡萄籽提取物（GSE）的一种以前未知的抗芳香化酶作用。我们建议将其转化为人类BC化学预防试验。 目的： 1.为了确定GSE是否显著抑制具有增加的BC风险的绝经后妇女的循环雌激素， 2.为了收集初步剂量信息， 3.确定生物利用度，以及 4.以评估人体安全性和耐受性。 方法：24名受试者将在2周安慰剂对照期后接受4个剂量水平的GSE治疗12周。将在预定的时间间隔抽取血液用于血清雌激素、原花青素浓度和芳香酶抑制测定。将在GSE前后检查骨代谢和肾上腺抑制标志物，并随访症状日志。