A Pilot Study to Evaluate the Role of Cyclooxygenase Pathway in Radiation Therapy and Chemoradiation Therapy Induced Mucositis in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Salivary levels of PGE2 and PGI2 during and after radiotherapy
研究概览
简要总结
This study will evaluate the role of cyclooxygenase pathways in radiation-induced and chemoradiation-induced mucositis.
详细描述
Oral mucositis is a significant toxicity of radiation therapy and chemoradiation therapy in head and neck cancer patients. However the mechanisms that induce such mucositis are not completely understood. Previous work evaluating mucositis in bone marrow transplant patients has suggested that prostaglandin levels may be associated with the appearance of mucositis.
The present study will measure the levels in saliva of the prostaglandins PGE2 and PGI2 before, during, immediately after, and several weeks after radiotherapy for head and neck cancer. These salivary levels will be correlated with clinical observation of mucositis and patient reporting of pain levels.
Improved understanding of the mechanism of mucositis may lead to the development of more effective targeted agents to prevent this problem.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven locoregional Stage 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx
- •Receiving radiation therapy or chemoradiation therapy to the oropharynx
- •Older than 18 years old
- •ECOG performance status of 0-2
- •Life expectancy greater than 2 months
- •Signed informed consent
排除标准
- •Previous chemotherapy for this malignancy
- •Previous radiotherapy to the head and neck
- •Other cancer diagnosis within the last 5 years except for non-melanoma skin cancer or non-metastatic prostate cancer
- •Patient taking NSAIDs
结局指标
主要结局
Salivary levels of PGE2 and PGI2 during and after radiotherapy
时间窗: 10 weeks after initiation of therapy
次要结局
- Patient reports of oral pain during and after radiation therapy(10 weeks after initiation of radiotherapy)
- Observed mucositis during and after radiotherapy(10 weeks after initiation of radiotherapy)
研究者
Claire Verschraegen
Professor of Medicine
University of Vermont