Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydroxychloroquine Sulfate Tablets, Placebo.
- Who it may be relevant to
- Registry conditions: Radiation-induced Oral Mucositis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
Evaluate the safety, tolerance and efficacy of hydroxychloroquine sulfate tablets the prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy
Interventions
- Drug Hydroxychloroquine Sulfate Tablets
the trial group use the hydroxychloroquine sulfate tablets (200mg/time, bid) - Other Placebo
the control group use the Placebo
Primary outcome measures
- the WHO grade of RIOM [Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Radiation Oncology — Chengdu
Publications
- Schrezenmeier E, Dorner T. Mechanisms of action of hydroxychloroquine and chloroquine: implications for rheumatology. Nat Rev Rheumatol. 2020 Mar;16(3):155-166. doi: 10.1038/s41584-020-0372-x. Epub 2020 Feb 7. PMID 32034323
Identifiers
NCT: NCT06939582 · 20241413