NCT06939582RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 29 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Evaluate the safety, tolerance and efficacy of hydroxychloroquine sulfate tablets the prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 158 (estimated)
- First submitted
- 20 Apr 2025
- Start date
- 22 Dec 2024
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Xingchen Peng
- Diseases
- Head and neck cancer
- NCT number
- NCT06939582
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 158
- From 22 Dec 2024 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with non head and neck parts in the radiotherapy area
- Recently taking or taking diuretics or other drugs known to interact with hydroxychloroquine sulfate tablets
Other illness
- 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
- Suffering from severe kidney disease, severe cardiovascular disease, myasthenia gravis, Parkinson's disease or epilepsy
- Other patients (combined with any serious other diseases) who the investigator believes are not suitable for participation in this study
Other
- Poor oral hygiene or severe periodontitis
- Retinopathy
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Radiation Oncology Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.