Placebo Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia

针灸预防辐射引起的口干症的安慰剂对照试验

• 批准号: 8043902
• 负责人: Lorenzo Cohen
• 金额: $ 72.62万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-02-15 至 2015-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8043902
• 关键词: Acupuncture procedure; Adverse effects; Amifostine; Area; Blinded; Buffers; Calcitonin Gene-Related Peptide; Cancer Hospital; Cancer Patient; Chewing Gum; China; Deglutition Disorders; Desire for food; Effectiveness; Europe; Expectancy; Head and Neck Cancer; Head and neck structure; Incidence; Lead; Measures; Nasopharynx Carcinoma; Nutritional; Outcome; Patient Self-Report; Patients; Pharmacologic Substance; Pilocarpine; Placebo Control; Proteins; Quality of life; Questionnaires; Radiation; Radiation therapy; Randomized; Research; Role; Saliva; Salivary; Severities; Sleep; Symptoms; Taste Perception; United States; Universities; University of Texas M D Anderson Cancer Center; Vasoactive Intestinal Peptide; Viscosity; Xerostomia; base; experience; improved; painful swallowing; pilot trial; placebo controlled study; prevent; primary outcome; programs; randomized placebo controlled trial; response; standard care; standard of care; success; treatment duration; treatment effect; treatment planning

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.

描述（由申请人提供）：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且常见的问题。口干症常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。美国和欧洲进行的研究表明，针灸可有效治疗辐射引起的口干症。较少研究使用针灸来预防辐射引起的口干症的严重程度并检查反应的持续时间。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的合作研究发现，针灸可以减轻已经出现口干症的患者的症状，并且可以预防口干症症状的严重程度并改善接受放射治疗的患者的生活质量。拟议的多中心、随机、安慰剂对照试验将研究针灸对接受头颈癌（M. D. Anderson）或鼻咽癌（NPC）（复旦大学肿瘤医院）放疗的患者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之一：真正的针灸；假针灸；或标准护理。将在放射治疗之前、期间和结束时以及之后 3、6 和 12 个月收集口干症的主观和客观测量结果。本研究的目的是： 1. 确定真正的针灸是否比假针灸或标准护理更有效地预防辐射引起的口干症的严重程度和发生率； 2. 使用未刺激和刺激的全唾液流速检查唾液流速的组间差异； 3. 检查真正的针灸是否比假针灸或标准护理能带来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； 5. 检查针灸疗效预期在预测结果中的作用。预期作为治疗效果调节剂的作用将得到彻底研究。 公共健康相关性：拟议的研究将检查针灸与放射治疗相结合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，那么这种类型的计划就可以作为护理标准纳入治疗计划中。