RecruitingPhase 1/2

Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis

China158 participantsStarted 2024-12-22

Plain-language 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

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

the WHO grade of RIOM

Timeframe: From the start of radiotherapy to 8 weeks after completion of radiotherapy

Trial details

NCT IDNCT06939582

SponsorXingchen Peng

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-01

Contact for this trial

Peng xingchen Professor

+86 1880606753 pxx2014@scu.edu.cn

View on ClinicalTrials.gov More Radiation-induced Oral Mucositis trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.