Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis
Evaluate the safety, tolerance and efficacy of hydroxychloroquine sulfate tablets the prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy
| Condition(s) | Radiation-induced Oral Mucositis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | Evaluate the safety, tolerance and efficacy of hydroxychloroquine sulfate tablets the prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy |
| Who can participate | 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 intera |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Xingchen Peng |
| Locations | Chengdu, Sichuan, China |
| Start date | 2024-12-22 |
| NCT ID | NCT06939582 |
| Official listing | https://clinicaltrials.gov/study/NCT06939582 |