RecruitingPhase 1Phase 2NCT06939582

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

Sponsor

Xingchen Peng

Enrollment

158 participants

Start Date

Dec 22, 2024

Study Type

INTERVENTIONAL

Conditions

Radiation-induced Oral Mucositis

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

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 Criteria8

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