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

针灸治疗慢性口干症的社区 III 期试验

• 批准号: 8643775
• 负责人: Lorenzo Cohen
• 金额: $ 42.47万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-04-10 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8643775
• 关键词: Acupuncture procedure; Aftercare; Amifostine; Applications Grants; Area; Buffers; Calcitonin Gene-Related Peptide; Cancer Hospital; Cancer Patient; Chewing Gum; China; Chronic; Clinic; Clinical Trials; Collection; Communities; Community Clinical Oncology Program; Data; Data Analyses; Deglutition Disorders; Dental Hygiene; Desire for food; Europe; Expectancy; Financial Support; Funding; Grant; Head and Neck Cancer; Head and neck structure; Intervention; Lead; Letters; Measures; National Cancer Institute; Nutritional; Outcome; Patient Recruitments; Patient Self-Report; Patients; Pharmacologic Substance; Phase; Phase III Clinical Trials; Pilocarpine; Placebo Control; Proteins; Protocols documentation; Quality Control; Quality of life; Radiation; Radiation therapy; Randomized; Reporting; Research; Research Personnel; Role; Saliva; Salivary; Severities; Sleep; Subgroup; Symptoms; Taste Perception; Training; United States; Universities; University of Texas M D Anderson Cancer Center; Vasoactive Intestinal Peptide; Viscosity; Work; Xerostomia; base; cost; data management; design; experience; head and neck cancer patient; improved; painful swallowing; placebo controlled study; prevent; randomized placebo controlled trial; response; standard care; standard of care; success; treatment duration; treatment effect

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.

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。这些试验中的许多很小，有方法上的弱点，很少有研究研究了推定的机制，并且在多个中心进行了研究。在德克萨斯大学医学博士安德森癌症中心进行的初步研究以及中国上海的富丹大学癌症医院的合作研究发现，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态性症状严重性，并改善接受放射治疗的患者的质量。拟议的多中心，基于社区的，随机的，安慰剂对照试验将检查针灸的影响，以减少放射线诱发的静脉血症的严重程度对完成头颈癌放射治疗后慢性静脉血管症患者的严重程度。完成放疗后至少9个月，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。在治疗之前和1个月后，将在治疗之前和1个月后采取主观和客观测量。这项研究的目的是 至：1。确定真正的针灸是比假针刺或标准护理更有效的，以降低辐射引起的静态症的严重程度； 2。探索报告针灸干预的初步反应的患者的反应持续时间； 3。使用唾液功能的客观度量检查唾液流动的群体差异； 4。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； 5。确定针灸对基于唾液的因素的影响，包括pH，缓冲能力和粘度以及总蛋白质，降钙素基因相关肽（CGRP）和血管活性肠道多肽（VIP）的水平；和6。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。