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

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。 这是一项I期剂量探索研究，目的是证明全食物 白色蘑菇提取物（WBM）可抑制芳香化酶诱导的雌激素 绝经后乳腺癌幸存者（BCS）的生物合成，并确定 诱导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，这被认为是 减轻WBM的抗癌作用。 本研究的次要目的是确定安全性， 通过一系列综合症状问卷调查评估人体WBM耐受性， 治疗前和治疗后骨代谢标志物，以及治疗前和治疗后 治疗综合血脂面板。 探索潜在的替代抗- 肿瘤机制，特别是WBM对细胞因子的影响，以及 先天性和适应性细胞免疫;并描述 从社区中招收不同族裔的学生进入中学， 预防试验BCS利用膳食补充剂干预， 以提高后续II期试验的可行性。

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.