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Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis

Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis

Recruiting
18-80 years
All
Phase 1/2

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Overview

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

Eligibility

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

Study details
    Radiation-induced Oral Mucositis

NCT06939582

Xingchen Peng

5 May 2025

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