Placebo Controlled Trial Of Acupuncture To Prevent Radiation-Induced 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。较少的研究检查了针灸在预防辐射引起的口干严重程度和检查反应持续时间方面的应用。由德克萨斯大学安德森癌症中心和中国上海复旦大学肿瘤医院合作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。提出的多中心、随机、安慰剂对照试验将研究针灸在预防头颈癌（m.d. Anderson）或鼻咽癌（NPC）（复旦肿瘤医院）放疗患者放射性口干的作用。在接受放射治疗之前，患者将被随机分为三组：真正的针灸；针灸;或者标准护理。在放射治疗之前、期间和结束时，以及3个月、6个月和12个月后，将收集口干症的主观和客观测量。本研究的目的是：1。确定在预防放射性口干症的严重程度和发生率方面，真针灸是否比假针灸或标准治疗更有效；2. 使用未受刺激和受刺激的全唾液流率检查各组唾液流率的差异；3. 检验真针是否能获得比假针或标准护理更好的总体生活质量；4. 确定针刺对唾液基础成分的影响作为潜在机制；和5。检查预期在预测结果中对针灸益处的作用。期望对治疗效果的调节作用将进行彻底的研究。

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. 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.