A Single Center, Open Label Phase II Clinical Trial of Hydroxychloroquine Sulfate Tablets for the Treatment of Radiation Stomatitis and Taste Disturbance in Intensity Modulated Radiotherapy for Head and Neck Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- the WHO grade of RIOM
研究概览
简要总结
Evaluate the safety, tolerance and efficacy of hydroxychloroquine sulfate tablets the prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients pathologically diagnosed with non-metastatic head and neck malignant tumors
- •Aged 18-80 years
- •Eastern Cooperative Oncology Group performance status of ≤2
- •Planning to receive definitive RT or postoperative adjuvant RT
- •Normal liver, kidney and bone marrow function
- •Sign informed consent
排除标准
- •Those who are known to be allergic to 4-aminoquinoline compounds or have more serious allergic constitution
- •Had a history of head and neck radiotherapy
- •Patients with non head and neck parts in the radiotherapy area
- •Poor oral hygiene or severe periodontitis
- •Suffering from severe kidney disease, severe cardiovascular disease, myasthenia gravis, Parkinson's disease or epilepsy
- •Recently taking or taking diuretics or other drugs known to interact with hydroxychloroquine sulfate tablets
- •Retinopathy
- •Other patients (combined with any serious other diseases) who the investigator believes are not suitable for participation in this study
研究组 & 干预措施
Control group
use the placebo
干预措施: Placebo (Other)
trial group
use the hydroxychloroquine sulfate tablets
干预措施: Hydroxychloroquine Sulfate Tablets (Drug)
结局指标
主要结局
the WHO grade of RIOM
时间窗: From the start of radiotherapy to 8 weeks after completion of radiotherapy
use the WHO Oral Toxicity Scale to evaluate the WHO grade of RIOM. WHO O grade: no representation of RIOM; WHO 1 grade: soreness and erythema; WHO 2 grade: erythema, ulcers and ability to eat solids; WHO 3 grade: ulcers, requiring liquid diet; WHO 4 grade: alimentation not possible. The higher scores mean a worse outcome.
次要结局
未报告次要终点
研究者
Xingchen Peng
Department of Radiation Oncology, Clinical Professor，West China Hospital
West China Hospital