Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis

Phase 1

Recruiting

• Conditions: Radiation-induced Oral Mucositis
• Interventions: Other: Placebo; Drug: Hydroxychloroquine Sulfate Tablets

• Registration Number: NCT06939582
• Lead Sponsor: Xingchen Peng

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-22
• Status Verified: 2025-04
• Study First Submitted: 2025-04-20
• Study First Submitted QC: 2025-04-20
• Study First Posted: 2025-04-23
• Last Update Submitted: 2025-04-26
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 158

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	use the placebo
trial group	Hydroxychloroquine Sulfate Tablets	use the hydroxychloroquine sulfate tablets

Primary Outcome Measures

Name	Time	Method
the WHO grade of RIOM	From the start of radiotherapy to 8 weeks after completion of radiotherapy	use the WHO Oral Toxicity Scale to evaluate the WHO grade of RIOM. WHO O grade: no representation of RIOM; WHO 1 grade: soreness and erythema; WHO 2 grade: erythema, ulcers and ability to eat solids; WHO 3 grade: ulcers, requiring liquid diet; WHO 4 grade: alimentation not possible. The higher scores mean a worse outcome.

Trial Locations

Locations (1)

Department of Radiation Oncology; 🇨🇳 Chengdu, Sichuan, China