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
基本信息
- 批准号:8643775
- 负责人:
- 金额:$ 42.47万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:Acupuncture procedureAftercareAmifostineApplications GrantsAreaBuffersCalcitonin Gene-Related PeptideCancer HospitalCancer PatientChewing GumChinaChronicClinicClinical TrialsCollectionCommunitiesCommunity Clinical Oncology ProgramDataData AnalysesDeglutition DisordersDental HygieneDesire for foodEuropeExpectancyFinancial SupportFundingGrantHead and Neck CancerHead and neck structureInterventionLeadLettersMeasuresNational Cancer InstituteNutritionalOutcomePatient RecruitmentsPatient Self-ReportPatientsPharmacologic SubstancePhasePhase III Clinical TrialsPilocarpinePlacebo ControlProteinsProtocols documentationQuality ControlQuality of lifeRadiationRadiation therapyRandomizedReportingResearchResearch PersonnelRoleSalivaSalivarySeveritiesSleepSubgroupSymptomsTaste PerceptionTrainingUnited StatesUniversitiesUniversity of Texas M D Anderson Cancer CenterVasoactive Intestinal PeptideViscosityWorkXerostomiabasecostdata managementdesignexperiencehead and neck cancer patientimprovedpainful swallowingplacebo controlled studypreventrandomized placebo controlled trialresponsestandard carestandard of caresuccesstreatment durationtreatment effect
项目摘要
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):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。其中许多试验规模较小,存在方法学缺陷,很少有研究调查假定的机制,而且没有一个是在多个中心进行的。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,并可以预防口干症症状的严重程度并改善患者的生活质量正在接受放射治疗。拟议的多中心、以社区为基础的随机、安慰剂对照试验将检查针灸对完成头颈癌放疗后慢性口干症患者降低辐射引起的口干症严重程度的效果。完成放射治疗至少 9 个月后,患者将被随机分入三组之一:真正的针灸;假针灸;或标准护理。将在治疗前和治疗后以及 1 个月和 6 个月后收集口干症的主观和客观测量结果。本研究的目的是
目的: 1. 确定真正的针灸是否比假针灸或标准护理更有效地减轻辐射引起的口干症的严重程度; 2. 探索对针灸干预有初步反应的患者的反应持续时间; 3. 使用唾液功能的客观测量来检查唾液流量的组间差异; 4. 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; 5.确定针灸对唾液pH、缓冲能力、粘度等因素以及总蛋白、降钙素基因相关肽(CGRP)和血管活性肠多肽(VIP)水平的影响; 6. 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。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Lorenzo Cohen其他文献
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$ 42.47万 - 项目类别:
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
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8458083 - 财政年份:2012
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Community-Based, Phase III Trial of acupuncture to treat chronic Xerostomia
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8296964 - 财政年份:2012
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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 - 财政年份:2011
- 资助金额:
$ 42.47万 - 项目类别:
Placebo Controlled Trial Of Acupuncture To Prevent Radiation-Induced Xerostomia
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$ 42.47万 - 项目类别:
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8635304 - 财政年份:2010
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