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Recruiting Phase 1, Phase 2 NCT06939582

Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis

Trial Parameters

Condition Radiation-induced Oral Mucositis
Sponsor Xingchen Peng
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 158
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2024-12-22
Completion 2025-06-01
Interventions
Hydroxychloroquine Sulfate TabletsPlacebo

Brief 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 Criteria

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

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