L-lysine in the Treatment of Oral Mucositis in Head and Neck Cancer Patients- A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Decrease in mucositis severity and time to complete response
研究概览
简要总结
This pilot clinical trial studies L-lysine in treating oral mucositis in patients undergoing radiation therapy with or without chemotherapy for head and neck cancer. L-lysine may lessen the severity of oral mucositis, or mouth sores in patients receiving radiation therapy with or without chemotherapy for head and neck cancer
详细描述
PRIMARY OBJECTIVES:
I. To determine the complete response rate, decrease in severity, and time to complete response of oral mucositis related to head and neck cancer irradiation and chemotherapy after using L-lysine supplementation daily.
SECONDARY OBJECTIVES:
I. To determine the functional impact of use of L-lysine for oral mucositis on daily life as measured by the Functional Life Index-Cancer (FLIC) Questionnaire total score.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Cytologically or pathologically proven cancer of the oropharynx, lip, oral cavity, larynx, hypopharynx, nasopharynx, and salivary glands
- •Predicted life expectancy greater than 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- •Renal function with a calculated creatinine clearance of 55 ml/min or greater, per Cockcroft-Gault formula
- •Patients undergoing radiation therapy with or without concurrent chemotherapy
- •Ability to understand and the willingness to sign a written informed consent document
- •Exclusion Criteria
- •Use of illicit drugs, alcohol abuse, or tobacco abuse during treatment
- •Subjects may not be receiving other investigational agents
- •Inability or unwillingness to comply with radiation therapy and chemotherapy regimens
- •Inability or unwillingness to take daily L-Lysine supplementation as prescribed
- •Use of arginine supplementation
- •History of renal failure or compromise
排除标准
- 未提供
结局指标
主要结局
Decrease in mucositis severity and time to complete response
时间窗: Weekly post-treatment until Grade 0 mucositis is achieved
Complete Response will be documented by complete resolution of oral mucositis, as defined by the Radiation Therapy Oncology Group (RTOG) grading scale. If the true percent of patients that respond is 20%, we will have a 90% chance of seeing at least 1 patient in 10 with a response. If none of the 10 patients show significant improvement in time to response, then we can be 90% confident that the true rate of significant improvement is less than 20%.
次要结局
- Improvement in quality of life(Weekly post-treatment until Grade 0 mucositis is achieved)