Community-Based, Phase III Trial of acupuncture to treat chronic Xerostomia

描述（由申请人提供）：口腔干燥（口干）是接受头颈部放射治疗的癌症患者的一个重要和常见问题。口干症通常严重损害患者的生活质量（QOL），目前可用的治疗方法成功率较低。在美国和欧洲进行的研究表明，针灸对治疗辐射引起的口干症是有用的。这些试验中有许多规模较小，方法学上存在缺陷，很少有研究调查了假定的机制，而且没有一项是在多个中心进行的。德克萨斯大学医学博士安德森癌症中心进行的初步研究和中国上海复旦大学肿瘤医院的合作研究发现，针灸可以减轻已经发生口干症的患者的症状，并可以预防口干症症状的严重程度，改善接受放疗的患者的生活质量。拟议的多中心，以社区为基础，随机，安慰剂对照试验将检查针灸的影响，以减少放射性口干的严重程度，慢性口干患者完成放射治疗头颈部癌症。在完成放疗后至少9个月，患者将被随机分配到三组之一：真针灸;假针灸;或标准治疗。将在治疗前后以及1个月和6个月后收集口干症的主观和客观指标。本研究的目的是 1.将第一个确定真针灸是否比假针灸或标准护理更有效地减轻辐射引起的口干症的严重程度; 2.探讨反应的持续时间在患者谁报告的初步反应，针灸干预; 3。使用唾液功能的客观测量检查唾液流量的组差异; 4.检查真正的针灸是否比假针灸或标准治疗更好的整体生活质量; 5.确定针灸对唾液的影响，包括pH、缓冲能力和粘度以及总蛋白、降钙素基因相关肽（CGRP）和血管活性肠多肽（VIP）的水平;和6.检查预期针灸的好处在预测结果中的作用。期望值作为治疗效果的调节剂的作用将被彻底研究。

DESCRIPTION (provided by applicant): Xerostomia (dry mouth) is an important and common problem among cancer patients who have received radiation treatment to the head and neck area. Xerostomia often severely impairs patients' quality of life (QOL), and current available treatments have a low success rate. Studies have been conducted in the United States and Europe suggesting that acupuncture is useful for treating radiation-induced xerostomia. Many of these trials were small with methodological weaknesses, few studies have investigated the putative mechanisms, and none were conducted at multiple centers. Initial research conducted at The University of Texas MD Anderson Cancer Center and collaborative research at Fudan University Cancer Hospital in Shanghai, China found that acupuncture can diminish symptoms in patients who had already developed xerostomia and could prevent the severity of xerostomia symptoms and improve QOL in patients undergoing radiotherapy. The proposed multi-center, community-based, randomized, placebo-controlled trial will examine the effects of acupuncture to reduce the severity of radiation-induced xerostomia in patients with chronic xerostomia after completing radiotherapy for head and neck cancer. At least 9 months after completing radiotherapy, patients will be randomized to one of three groups: true acupuncture; sham acupuncture; or standard care. Subjective and objective measures of xerostomia will be collected prior to and after treatment, as well as 1 and 6 months later. The aims of this study are to: 1. Determine if true acupuncture is more effective than sham acupuncture or standard care for reducing the severity of radiation-induced xerostomia; 2. Explore the duration of response in patients who report an initial response to the acupuncture intervention; 3. Examine group differences in saliva flow using an objective measure of salivary function; 4. Examine whether true acupuncture results in better overall QOL than sham acupuncture or standard of care; 5. Determine the effects of acupuncture on saliva based factors including pH, buffering capacity, and viscosity as well as levels of total protein, calcitonin- gene-related peptide (CGRP), and vasoactive intestinal polypeptide (VIP); and 6. Examine the role of expectancy for the benefits of acupuncture in predicting outcomes. The role of expectancy as a moderator of the effects of treatment will be thoroughly examined.