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Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis

RECRUITINGPhase 1/2Sponsored by Xingchen Peng
Actively Recruiting
PhasePhase 1/2
SponsorXingchen Peng
Started2024-12-22
Est. completion2025-06-01
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06939582

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions2

CancerRadiation-induced Oral Mucositis

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