CLINICAL TRIAL: A TRANSLATIONAL BREAST CANCER PREVENTION TRIAL MUSHROOM POWDER I

临床试验：转移性乳腺癌预防试验蘑菇粉 I

• 批准号: 7982091
• 负责人: MELANIE R PALOMARES
• 金额: $ 2.2万
• 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/7982091
• 关键词: Aftercare; Agaricales; Anabolism; Aromatase; Biological Availability; Breast Cancer Prevention Trial; Cancer Survivor; Cellular Immunity; Clinical Research; Clinical Trials; Communities; Computer Retrieval of Information on Scientific Projects Database; Dose; Estrogens; Food; Funding; Grant; Human; Institution; Intervention; Lipids; Malignant Neoplasms; Phase; Phase II Clinical Trials; Postmenopause; Powder dose form; Questionnaires; Research; Research Personnel; Resources; Safety; Secondary Prevention; Source; Symptoms; United States National Institutes of Health; Unsaturated Fatty Acids; bone metabolism; cytokine; dietary supplements; experience; malignant breast neoplasm; tumor

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. This is a Phase I dose-finding study with objectives to show that a whole food extract of white button mushrooms (WBM) can inhibit aromatase-induced estrogen biosynthesis in postmenopausal breast cancer survivors (BCS), and to determine the optimal daily dose to induce this effect; and to determine the bioavailability of C-18 unsaturated fatty acids (CUFA), which are thought to moderate the anti-cancer effects of WBM. The secondary objectives of this study are to determine safety and tolerability of WBM in humans via serial comprehensive symptom questionnaires, pre- and post-treatment markers of bone metabolism, and pre- and post- treatment comprehensive lipid panels. To explore potential alternate anti- tumor mechanisms, specifically the effect of WBM on cytokines as well as innate and adaptive cellular immunity; and to describe barriers experienced in recruitment of ethnically diverse subjects from the community into a secondary prevention trial BCS utilizing a dietary supplement intervention, in an effort to enhance feasibility of a subsequent Phase II trial.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项第一阶段的剂量发现研究，目的是证明一种完整的食物 白蘑菇提取物(WBM)抑制芳香化酶诱导的雌激素 绝经后乳腺癌存活者(BC)的生物合成 诱发这种效应的最佳每日剂量；并确定 C-18不饱和脂肪酸(CUFA)的生物利用度 对WBM抗癌作用有一定的调节作用。 这项研究的次要目标是确定安全性和 通过系列综合症状问卷对人体对白血球蛋白的耐受性 治疗前和治疗后骨代谢指标，治疗前后 治疗综合脂类面板。探索潜在的替代反- 肿瘤机制，特别是WBM对细胞因子以及 先天和获得性细胞免疫；并描述在 从社区招募不同种族的科目进入中学 使用膳食补充剂干预的预防试验BCS 以增强随后第二阶段试验的可行性。