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.

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National Institute of Nursing Research
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