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

描述(申请人提供)：口干症(口干)是接受过头颈部放射治疗的癌症患者的一个重要而常见的问题。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。这些试验中的许多都是小规模的，存在方法学上的缺陷，很少有研究调查可能的机制，也没有一个是在多个中心进行的。在德克萨斯大学MD安德森癌症中心进行的初步研究和上海复旦大学肿瘤医院的合作研究中，中国发现，针灸可以减轻已经出现口干症的患者的症状，并可以预防口干症的严重程度，提高接受放射治疗的患者的生活质量。这项拟议的多中心、社区、随机、安慰剂对照试验将检验针灸在完成头颈部癌症放射治疗后减轻慢性口干症患者放射性口干症严重程度的效果。在完成放射治疗至少9个月后，患者将被随机分为三组：真针灸、假针灸或标准护理。口干症的主观和客观测量将在治疗前和治疗后，以及治疗后1个月和6个月收集。这项研究的目的是 目的：1.确定真正的针灸在减轻放射性口干症的严重程度方面是否比假针灸或标准护理更有效；2.探索对针灸干预有初步反应的患者的反应持续时间；3.使用唾液功能的客观测量来检查唾液流量的组别差异；4.检验真针灸是否比假针灸或标准护理更好地改善整体生活质量；5.确定针刺对唾液因素的影响，包括pH值、缓冲能力、黏度以及总蛋白、降钙素基因相关肽(CGRP)和血管活性肠肽(VIP)的水平；6.检查预期针灸效果在预测结果中的作用。将彻底审查预期作为治疗效果的调节因素的作用。

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.