Placebo Controlled Trial Of Acupuncture To Prevent Radiation-Induced 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。较少的研究研究了针灸在预防辐射引起的口干症严重程度和检查反应持续时间方面的使用。由德克萨斯大学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发现，针灸可以减轻已经出现口干症状的患者的症状，并可以预防口干症状的严重程度，提高接受放射治疗的患者的生活质量。这项拟议的多中心、随机、安慰剂对照试验将检验针灸在头颈癌(M.D.Anderson)或鼻咽癌(NPC)(复旦肿瘤医院)接受放射治疗的患者中预防辐射引起的口干症的效果。在接受放射治疗之前，患者将被随机分为三组：真针灸、假针灸或标准护理。在放射治疗之前、期间和结束时，以及3、6和12个月后，收集口干症的主观和客观测量。这项研究的目的是：1.确定在预防放射性口干症的严重程度和发病率方面，真正的针灸是否比假针灸或标准护理更有效；2.使用未刺激和刺激的全唾液流率来检查各组唾液流率的差异；3.检验真正的针灸是否比假针灸或标准护理产生更好的整体生活质量；4.确定针灸对唾液成分的影响作为潜在机制；以及5.检查预期针灸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。 公共卫生相关性：这项拟议的研究将检验针灸和放射治疗对头颈癌患者的疗效。如果我们发现针灸可以减少接受放射治疗的患者所经历的副作用，那么这种类型的方案可以作为护理的标准纳入治疗计划。

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. Less research has examined the use of acupuncture at preventing the severity of radiation- induced xerostomia and examining the duration of response. Initial research conducted at The University of Texas M. D. 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, randomized, placebo-controlled trial will examine the effects of acupuncture at preventing radiation-induced xerostomia in patients undergoing radiotherapy for head and neck cancer (M. D. Anderson) or nasopharyngeal carcinoma (NPC) (Fudan Cancer Hospital). Prior to receiving radiation treatment, 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, during, and at the end of the radiation treatment, as well as 3, 6, and 12 months later. The aims of this study are to: 1. Determine if true acupuncture is more effective than sham acupuncture or standard care for preventing the severity and incidence of radiation-induced xerostomia; 2. Examine group differences in salivary flow rates using unstimulated and stimulated whole saliva flow rates; 3. Examine whether true acupuncture results in better overall QOL than sham acupuncture or standard of care; 4. Determine the effects of acupuncture on saliva-based constituents as potential mechanisms; and 5. 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. PUBLIC HEALTH RELEVANCE: The proposed study will examine the efficacy of incorporating acupuncture alongside radiotherapy for patients with head and neck cancer. If we find that acupuncture diminishes the side effects experienced by patients undergoing radiotherapy, then this type of program can be incorporated into the treatment plan as the standard of care.