Phase I Study of Noni in Cancer Patients

描述(申请人提供)：诺丽在癌症中的I期研究 患者是互补性和系统性研究的第一步。 替代医学(CAM)实践借鉴亚洲和太平洋岛屿 治疗以控制癌症及其相关症状的文化传统。 诺丽，从巴戟天或印度桑树中提取，是 包括在夏威夷土著、其他太平洋地区的传统药典中 岛民和亚洲人，并已被用来治疗各种疾病 几百年来。它现在被癌症患者普遍服用，因为 据称对这种疾病有用处，尽管几乎没有科学依据 支持或反驳这些说法的证据。一家大型营销企业 至少有11家不同的供应商支持这种食品补充剂 人气。这项研究将启动的广泛的长期目标是 确定诺丽提取物对癌症患者的有用性。假说 要测试的是，指定剂量的诺丽为癌症患者提供了一种 对毒性特征有足够的益处，可以作为一种治疗方法。 这项研究的具体目标是： 1.测定胶囊最大耐受量375毫克 冷冻干燥诺丽果萃取物。 2.定义与摄入诺丽有关的毒性。 3.收集有关诺丽在以下方面的疗效的初步信息 抗肿瘤和症状控制特性，帮助选择特定的患者 随后的第二阶段研究。 4.确定提取物的化学成分，可用于 描述诺丽食品补充剂的生物利用度和药代动力学。

DESCRIPTION (provided by applicant): This Phase I study of noni in cancer patients represents a first step in the systematic study of Complementary and Alternative Medicine (CAM) practices that draw on Asian and Pacific Island cultural traditions of healing to control cancer and its related symptoms. Noni, extracted from Morinda citifolia or the Indian mulberry plant, is included in the traditional pharmacopoeias of Native Hawaiians, other Pacific Islanders and Asian populations, and has been used to treat various diseases for hundreds of years. It is now commonly taken by cancer patients based on purported usefulness in the disease although there is little scientific evidence to either support or refute these claims. A large marketing enterprise and at least eleven different suppliers supports the food supplement's popularity. The broad long range objectives which this study will initiate are to define the usefulness of noni extracts for cancer patients. The hypothesis to be tested is that noni at a specified dosing provides cancer patients with a sufficient benefit to toxicity profile to be useful as a therapeutic. Specific aims of this study are: 1. Determine the maximum tolerated dose of capsules containing 375mg of freeze-dried noni fruit extract. 2. Define toxicities associated with the ingestion of noni. 3. Collect preliminary information on the efficacy of noni in respect to anti-tumor and symptom control properties to help select specific patients for subsequent Phase II studies. 4. Identify chemical constituents of the extract that can be used to characterize the bioavailability and pharmacokinetics of noni food supplement.