Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis

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

Evaluate the safety, tolerance and efficacy of hydroxychloroquine sulfate tablets the prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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