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

描述（申请人提供）：口干是头颈部接受放射治疗的癌症患者的一个重要且常见的问题。口干症通常严重影响患者的生活质量，目前可用的治疗方法成功率很低。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。其中许多试验规模小，方法有缺陷，很少有研究调查了假定的机制，而且没有一个是在多个中心进行的。德克萨斯大学MD安德森癌症中心和中国上海复旦大学肿瘤医院进行的初步研究发现，针灸可以减轻已经发生口干症的患者的症状，可以预防口干症症状的严重程度，并改善接受放疗的患者的生活质量。该多中心、社区、随机、安慰剂对照试验将检验针灸对头颈癌放疗后慢性口干患者放射性致口干严重程度的影响。放疗完成后至少9个月，患者将随机分为三组：真针灸组；针灸;或者标准护理。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测量数据。本研究的目的是

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.