Using hydroxychloroquine to prevent and treat oral mucositis from radiation therapy
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
This study is testing if hydroxychloroquine can help prevent and treat mouth sores in people getting radiation therapy for head and neck cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06939582 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerance, and efficacy of hydroxychloroquine sulfate tablets in preventing and treating oral mucositis and dysgeusia in patients undergoing radiotherapy for non-metastatic head and neck malignant tumors. Participants will be randomly assigned to receive either hydroxychloroquine or a placebo. The study aims to determine whether hydroxychloroquine can effectively reduce the incidence and severity of oral mucositis associated with radiation treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with non-metastatic head and neck cancers who are scheduled to receive radiotherapy.
Not a fit: Patients with a history of head and neck radiotherapy or those with severe underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients undergoing radiotherapy by reducing painful oral mucositis.
How similar studies have performed: While there have been studies on the use of hydroxychloroquine for various conditions, this specific application for radiation-induced oral mucositis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chengdu, Sichuan
- Department of Radiation Oncology — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Peng xingchen Professor
- Email: pxx2014@scu.edu.cn
- Phone: +86 1880606753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.