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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

基本信息

批准号：
7594631
负责人：
jane fall-dickson
金额：
$ 16万
依托单位：
NATIONAL INSTITUTE OF NURSING RESEARCH
依托单位国家：
美国
项目类别：
财政年份：
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/7594631
关键词：
Acute Age Anti-Inflammatory Agents Anti-inflammatory Atrophic Autologous Binding Biological Blood Cancer Center Chimeric Proteins Clinical Trials Data Monitoring Committees Community Clinical Oncology Program Complex Condition Data Dental Dental Clinics Edema Erythema Etanercept Growth Factor Healed Incidence Inflammation Inflammatory Inflammatory Response Informed Consent Injury Institutes Intervention Measures Mediator of activation protein Monitor Mouthwash Mucous Membrane National Cancer Institute Oral Oral cavity Oral mucous membrane structure Oropharyngeal Pain Participant Pathogenesis Patient Care Patients Peripheral Blood Stem Cell Placebos Polymerase Chain Reaction Prevention Protocols documentation Purpose Quality of life Randomized Randomized Controlled Clinical Trials Recruitment Activity Research Role Safety Sampling Schedule Science Severities Signal Transduction Site Specific qualifier value Stomatitis Techniques Testing Time Tissues Toxic effect Training Treatment-Related Cancer Tumor Necrosis Factor-alpha Tumor Necrosis Factors Ulcer Visit Writing chemotherapy craniofacial cytokine day experience healing human TNF protein improved insight novel oncology oral condition prevent receptor tool

项目摘要

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.

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。