Eval of Efficacy and Mechs of Anti-inflammatory Intervention for Mucosal Injury

粘膜损伤抗炎干预的疗效及机制评价

• 批准号: 8350028
• 负责人: jane fall-dickson
• 金额: $ 17.01万
• 依托单位: NATIONAL INSTITUTE OF NURSING RESEARCH
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8350028
• 关键词: Acute; Anti-Inflammatory Agents; Anti-inflammatory; Atrophic; Binding; Biological; Blood; Bone Marrow Transplantation; Cancer Center; Chimeric Proteins; Clinical; Clinical Services; Clinical Trials; Community Clinical Oncology Program; Complex; Data; Development; Edema; Enrollment; Erythema; Etanercept; Hematopoietic stem cells; Incidence; Inflammation; Inflammatory; Informed Consent; Injury; Institutional Review Boards; Intervention; Laboratories; Maryland; Measures; Mediator of activation protein; Mouthwash; Mucous Membrane; National Cancer Institute; National Institute of Nursing Research; Oral; Oral cavity; Oropharyngeal; Pain; Pathogenesis; Patient Care; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Placebos; Prevention; Principal Investigator; Procedures; Protocols documentation; Quality of life; Randomized; Randomized Controlled Clinical Trials; Recruitment Activity; Research Personnel; Role; Sampling; Schedule; Science; Self-Administered; Severities; Shipping; Ships; Site; Stem cell transplant; Stomatitis; Testing; Tissues; Toxic effect; Training; Treatment-Related Cancer; Tumor Necrosis Factor-alpha; Ulcer; United States National Institutes of Health; Universities; Visit; Writing; chemotherapy; clinical research site; conditioning; design; efficacy testing; experience; improved; insight; novel; oncology; oral condition; prevent; programs; receptor; tool; treatment strategy

This clinical trial was designed to test the efficacy of an etanercept mouthwash versus placebo for chemotherapy related stomatitis in the hematopoietic stem cell transplant (HSCT) setting. The conditioning chemotherapy for HSCT at the Clinical Center, NIH, transitioned to non stomatogenic protocols soon after protocol Institutional Review Board (IRB) approval. The National Cancer Institute sponsored Community Clinical Oncology Program (CCOP), Cancer Centers of the Carolinas, Greenville, SC, was added as the second clinical site following the site initiation visit in July 2006 and interrater reliability training in November, 2006. Although CCOP staff followed their standard recruitment procedures, they recruited only 2 subjects. All subjects gave written informed consent. All data were collected, and study drug was self administered by subjects per protocol schedule. Etanercept mouthwash and placebo was prepared by the Pharmaceutical Development Service, Clinical Center, NIH. Stomatitis and oropharyngeal pain were measured per protocol procedures, and biological samples were shipped to the National Institute of Nursing Research, NIH, laboratory. The University of Maryland IRB approved this protocol in January 2009 for implementation through the Blood and Marrow Transplantation Program, University of Maryland Greenebaum Cancer Center. The plan to add this third site was changed because of inadeaute recruitment at the first two sites. Therefore the investigators closed the study to subject enrollment in August of 2010. The principal investigator requested study termination at the July 27, 2011 NIH Combined Neurosensory IRB, with study termination completed by this IRB on 9/13/2011.

本临床试验旨在检测依那西普漱口水与安慰剂相比在造血干细胞移植（HSCT）背景下治疗化疗相关口腔炎的疗效。NIH临床中心的HSCT预处理化疗方案在方案机构审查委员会（IRB）批准后不久就过渡到非致口原性方案。在2006年7月的临床试验机构启动访视和2006年11月的评估者间可靠性培训后，将美国国家癌症研究所申办的社区临床肿瘤学项目（CCOP），南卡罗来纳州格林维尔的美国癌症中心添加为第二个临床试验机构。尽管CCOP工作人员遵循了标准招募程序，但他们只招募了2名受试者。所有受试者均提供了书面知情同意书。收集所有数据，受试者按照方案时间表自行给予研究药物。依那西普漱口水和安慰剂由NIH临床中心药物开发服务部制备。按照方案程序测量口腔炎和口咽疼痛，并将生物样本运送至国立护理研究所（NIH）实验室。马里兰州大学IRB于2009年1月批准了本方案，通过马里兰州大学Greenebaum癌症中心的血液和骨髓移植项目实施。增加第三个研究中心的计划因前两个研究中心招募不足而改变。因此，研究者于2010年8月关闭了研究，不允许受试者入组。主要研究者于2011年7月27日在NIH联合神经感觉IRB要求终止研究，该IRB于2011年9月13日完成研究终止。