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: 8230482
• 负责人: Lorenzo Cohen
• 金额: $ 61.72万
• 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/8230482
• 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; public health relevance; 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）：静态（口干）是接受过针对头颈部面积放射治疗的癌症患者中的一个重要且常见的问题。静态症通常严重损害患者的生活质量（QOL），并且当前可用的治疗率较低。在美国和欧洲进行了研究，表明针灸对于治疗辐射引起的静态症很有用。较少的研究检查了针灸的使用，以防止辐射诱导的静态症的严重程度并检查反应持续时间。在德克萨斯大学M. D. Anderson癌症中心进行的初步研究以及中国上海Fudan University Cancer Hospital的合作研究发现，针灸可以减少已经患有心血管疾病的患者的症状，并可以防止患者患者的静脉病毒症状严重程度，并改善接受放射治疗的患者。拟议的多中心，随机，安慰剂对照试验将检查针灸对预防辐射诱导的静态症的影响，对接受头颈癌的放疗（M. D. Anderson）或鼻咽癌（NPC）（NPC）（Fudan Cancer Cancer Hospital）的患者。在接受辐射治疗之前，患者将被随机分为三组之一：真正的针灸；假针刺；或标准护理。在放射线处理之前，期间和12个月后，将在，期间和12个月后，在辐射治疗的结束之前，之中和结束前，在辐射治疗结束之前和结束时采取主观和客观的测量。这项研究的目的是：1。确定真正的针灸是否比假针刺或标准护理更有效，以防止辐射引起的静脉炎的严重程度和发生率； 2。使用未刺激和刺激的整个唾液流量检查唾液流量的群体差异； 3。检查真正的针灸是否比假针刺或护理标准会导致整体QoL更好； 4。确定针灸对基于唾液的成分作为潜在机制的影响；和5。检查预期对针灸预测预测结果中的好处的作用。预期作为治疗作用的主持人的作用将得到彻底检查。 公共卫生相关性：拟议的研究将检查将针灸与放射疗法一起为头颈癌患者纳入放射治疗的功效。如果我们发现针灸会减少接受放疗的患者所经历的副作用，那么可以将这种类型的程序纳入治疗计划中。