Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy
研究概览
简要总结
Oral mucositis refers to ulcerative lesions of the oral mucosa that occur due to radiation therapy given for treatment of head and neck cancer. These lesions are painful, compromise nutrition and quality of life and may necessitate interruptions in radiation therapy, thus adversely affecting cancer therapy outcomes. This study examined the use of an anti-inflammatory medicine to reduce pain and severity of oral mucositis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will be receiving at least 5000 centigray (cGy) radiation therapy to at least 2 of 14 pre-defined areas in the oral cavity.
- •Women of childbearing potential must agree to use a medically accepted form of contraception during the course of the study. Women of childbearing potential must have a documented negative pregnancy test within fourteen days of enrollment in the study.
- •Patient's willing and able to provide written informed consent for the study.
排除标准
- •Patients with known hypersensitivity to celecoxib or other COX-2 inhibitors.
- •Patients who have experienced asthma, urticaria, or allergic-type reactions after taking salicylates (e.g. aspirin) or Non-steroidal anti-inflammatory drugs (NSAIDs).
- •Patients who have demonstrated allergic-type reactions to sulfonamides.
- •Patients with a history of gastric, esophageal, pyloric channel or duodenal ulcer disease or gastrointestinal bleeding.
- •Patients with a history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) or pancreatic disease.
- •Patients with severe hepatic impairment.
- •Patients with advanced renal disease.
- •Patients with a significant bleeding disorder.
- •Patients under the age of 18 or over the age of
- •Women who are pregnant or nursing.
- •Patients with a history of thromboembolic events including myocardial infarction, pulmonary embolism, deep venous thrombosis, transient ischemic attack and ischemic cerebrovascular accident (stroke).
- •Patients who have had coronary angioplasty, coronary artery bypass surgery or another cardiac revascularization procedure.
- •Patients with a history of a cardiac arrhythmia requiring anti-arrhythmic therapy, angina pectoris or congestive heart failure.
研究组 & 干预措施
I- Celecoxib
干预措施: celecoxib (Drug)
II
干预措施: placebo (Drug)
结局指标
主要结局
Clinical Oral Mucosal Injury Score at Cumulative Radiation Dose of 5000 cGy
时间窗: 5 weeks from start of radiation therapy (5000 cGy)
Oral Mucositis Assessment Scale (OMAS) was used to assess oral mucosal injury during the period of radiation therapy. This validated scale scores ulceration and erythema independently at nine specified sites in the oral cavity. Ulceration is scored from 0-3 based on size of lesion and erythema is scored from 0-2 based on severity of erythema. The sum of scores is then divided by 9. The mean OMAS score at a cumulative radiation dose of 5000 cGy (approximately 5 weeks of treatment) was compared between groups.
次要结局
- Evaluation of Pain Severity at 5000 cGy Radiation(5 weeks from start of radiation therapy (cumulative dose of 5000 cGy))
研究者
Rajesh Lalla
Associate Professor, Oral Medicine
UConn Health