Status:
RECRUITING
Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis
Lead Sponsor:
Xingchen Peng
Conditions:
Radiation-induced Oral Mucositis
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
December 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2025
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT06939582
Start Date
December 22 2024
End Date
June 20 2025
Last Update
April 29 2025
Active Locations (1)
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1
Department of Radiation Oncology
Chengdu, Sichuan, China, 610000