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

CCOP研究中心启动访视于2006年7月成功完成，评估者间可靠性培训于2006年11月2日完成。CCOP于2007年获批用于受试者招募。在Greenville，SC，CCOP招募了1例患者参与研究。获得了该受试者的书面知情同意书。患者随机接受依那西普漱口水或安慰剂，按照方案时间表给药。测量口腔炎和口咽疼痛，并按照方案采集生物样本。受试者选择在BMT第+4天脱离方案。所有数据和生物样本均由NINR研究协调中心适当接收。

The CCOP site initiation visit was successfully completed in July 2006, and the interrater reliability training was completed November 2, 2006. The CCOP was approved for subject recruitment in 2007. One patient has been recruited to the study at the Greenville, SC, CCOP. Written informed consent was obtained from this participant. Patient was randomized to receive either etanercept mouthwash or placebo, which was administered by protocol schedule. Stomatitis and oropharyngeal pain were measured and biological samples were collected per protocol. The subject chose to take himself off protocol on BMT day +4. All data and biological samples were received appropriately by the NINR Study Coordinating Center.