RecruitingPhase 1Phase 2NCT06939582

Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis

A Single Center, Open Label Phase II Clinical Trial of Hydroxychloroquine Sulfate Tablets for the Treatment of Radiation Stomatitis and Taste Disturbance in Intensity Modulated Radiotherapy for Head and Neck Cancer


Sponsor

Xingchen Peng

Enrollment

158 participants

Start Date

Dec 22, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether hydroxychloroquine — a medication usually used for lupus and malaria — can help prevent or reduce mouth sores (oral mucositis) caused by radiation therapy in patients being treated for head and neck cancers. Radiation-induced mouth sores are a very painful side effect that can disrupt eating and treatment. **You may be eligible if...** - You have a confirmed diagnosis of non-metastatic head and neck cancer - You are between 18 and 80 years old - You are scheduled for radiation therapy (either as main treatment or after surgery) - Your liver, kidney, and bone marrow function are within normal limits **You may NOT be eligible if...** - You have a known allergy to hydroxychloroquine or related compounds - You have received prior radiation therapy to the head and neck area - You have poor oral hygiene or severe gum disease - You have serious kidney disease, heart disease, myasthenia gravis, Parkinson's, or epilepsy - You have eye disease (retinopathy) - You are taking medications known to interact with hydroxychloroquine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHydroxychloroquine Sulfate Tablets

the trial group use the hydroxychloroquine sulfate tablets (200mg/time, bid)

OTHERPlacebo

the control group use the Placebo


Locations(1)

Department of Radiation Oncology

Chengdu, Sichuan, China

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NCT06939582


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