Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis (RIOM)

Xingchen Peng

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Radiation-induced Oral Mucositis

Treatments: Other: Placebo; Drug: Hydroxychloroquine Sulfate Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT06939582

20241413

Details and patient eligibility

About

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

Enrollment: 158 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

use the placebo

Treatment:

Other: Placebo

trial group

Experimental group

Description:

use the hydroxychloroquine sulfate tablets

Treatment:

Drug: Hydroxychloroquine Sulfate Tablets