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

这项临床试验旨在测试依那西普含漱液与安慰剂在造血干细胞移植(HSCT)环境下治疗化疗相关性口炎的疗效。美国国立卫生研究院临床中心的HSCT条件化疗在方案机构审查委员会(IRB)批准后不久就过渡到非口腔方案。美国国家癌症研究所赞助的社区临床肿瘤学项目(CCOP)，南卡罗来纳州格林维尔的卡罗莱纳州癌症中心，在2006年7月的现场启动访问和2006年11月的评审员可靠性培训之后，被添加为第二个临床站点。虽然CCOP的工作人员遵循了他们的标准招聘程序，但他们只招聘了2名受试者。所有受试者均给予书面知情同意。所有数据都被收集起来，研究药物由受试者按照方案时间表自行给药。依那西普漱口水和安慰剂是由美国国立卫生研究院临床中心药物开发服务部门制备的。按照程序测量口腔炎和口咽部疼痛，并将生物样本运往美国国立卫生研究院国家护理研究所实验室。马里兰大学IRB于2009年1月批准了这项协议，通过马里兰大学Greenebaum癌症中心的血液和骨髓移植计划来实施。由于前两个地点的招聘不多，增加第三个地点的计划发生了变化。因此，研究人员在2010年8月结束了这项研究，研究和数据分析正在进行中，最终的试点研究数据和CCOP受试者的样本得到了国家牙科和颅面研究所IRB的批准。

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 with study and data analysis ongoing with final pilot study data and CCOP subjects' samples with the approval of the National Institute of Dental and Craniofacial Research IRB.