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: 8149619
• 负责人: jane fall-dickson
• 金额: $ 19.04万
• 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/8149619
• 关键词: Anti-Inflammatory Agents; Anti-inflammatory; Injury; Intervention

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.

该临床试验旨在测试依那西普漱口水与安慰剂相比，在造血干细胞移植 (HSCT) 环境中治疗化疗相关口腔炎的疗效。在机构审查委员会 (IRB) 批准方案后不久，NIH 临床中心的 HSCT 预处理化疗就转为非造口方案。继 2006 年 7 月的现场启动访问和 2006 年 11 月的参与者间可靠性培训之后，国家癌症研究所赞助的社区临床肿瘤学计划 (CCOP)、位于南卡罗来纳州格林维尔的卡罗来纳州癌症中心被添加为第二个临床中心。尽管 CCOP 工作人员遵循其标准招募程序，但他们只招募了 2 名受试者。所有受试者均签署了书面知情同意书。收集所有数据，并根据方案时间表由受试者自行施用研究药物。依那西普漱口水和安慰剂由 NIH 临床中心药物开发服务处制备。按照方案程序测量口腔炎和口咽疼痛，并将生物样本运送到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 月批准了该方案，通过马里兰大学格林鲍姆癌症中心的血液和骨髓移植计划实施。由于前两个站点的招聘不充分，增加第三个站点的计划被更改。因此，研究人员于 2010 年 8 月结束了该研究的受试者招募，并在国家牙科和颅面研究所 IRB 的批准下，对最终试点研究数据和 CCOP 受试者样本进行了研究和数据分析。