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.
| Fall-Dickson, Jane M; Ramsay, Edward S; Castro, Kathleen et al. (2007) Oral mucositis-related oropharyngeal pain and correlative tumor necrosis factor-alpha expression in adult oncology patients undergoing hematopoietic stem cell transplantation. Clin Ther 29 Suppl:2547-61 |
