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

本临床试验旨在测试依那西普漱口水与安慰剂对造血干细胞移植（HSCT）化疗相关口炎的疗效。美国国立卫生研究院临床中心的HSCT调理化疗在方案机构审查委员会（IRB）批准后不久就过渡到非造口方案。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卡罗来纳州癌症中心，在2006年7月的现场启动访问和2006年11月的相互可靠性培训之后，被添加为第二个临床站点。尽管CCOP工作人员遵循了他们的标准招募程序，但他们只招募了2名受试者。所有受试者均给予书面知情同意。收集所有数据，受试者按照方案计划自行给药。依那西普漱口水和安慰剂由美国国立卫生研究院临床中心药物开发服务处制备。根据方案程序测量口腔炎和口咽疼痛，并将生物样本运送到国立卫生研究院护理研究所实验室。马里兰大学医学审查委员会于2009年1月批准了该协议，并通过马里兰大学格林鲍姆癌症中心血液和骨髓移植项目实施。增加第三个地点的计划因前两个地点招聘不足而改变。因此，研究人员于2010年8月结束了该研究的受试者登记。首席研究员于2011年7月27日在NIH联合神经感觉IRB申请终止研究，该IRB于2011年9月13日完成研究终止。

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.