Phase I Study of Noni in Cancer Patients

描述（由申请人提供）：诺丽在癌症中的I期研究 患者代表了系统研究互补和 替代医学（CAM）的做法，借鉴亚洲和太平洋岛屿 治疗的文化传统，以控制癌症及其相关症状。 诺丽，从巴戟天或印度桑葚植物中提取， 包括在夏威夷原住民的传统药典中，其他太平洋 岛民和亚洲人口，并已被用于治疗各种疾病 数百年它现在通常被癌症患者服用， 据说对这种疾病有用，尽管几乎没有科学的 证据来支持或反驳这些说法。大型营销企业 至少有11个不同的供应商支持食品补充剂的 人气这项研究将提出的广泛的长期目标是 以确定诺丽提取物对癌症患者的有用性。的假设 要测试的是，诺丽在特定剂量提供癌症患者， 对毒性特征有足够益处以用作治疗剂。 这项研究的具体目标是： 1.测定含有375 mg的 冻干诺丽果提取物。 2.定义与摄入诺丽果有关的毒性。 3.收集有关诺丽果在以下方面功效的初步信息： 抗肿瘤和症状控制特性，以帮助选择特定的患者， 随后的II期研究。 4.确定提取物的化学成分， 表征诺丽果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.