Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis
NCT ID: NCT06939582
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
158 participants
INTERVENTIONAL
2024-12-22
2025-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group
use the placebo
Placebo
the control group use the Placebo
trial group
use the hydroxychloroquine sulfate tablets
Hydroxychloroquine Sulfate Tablets
the trial group use the hydroxychloroquine sulfate tablets (200mg/time, bid)
Interventions
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Hydroxychloroquine Sulfate Tablets
the trial group use the hydroxychloroquine sulfate tablets (200mg/time, bid)
Placebo
the control group use the Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Xingchen Peng
OTHER
Responsible Party
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Xingchen Peng
Department of Radiation Oncology, Clinical Professor，West China Hospital
Locations
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Department of Radiation Oncology
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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20241413
Identifier Type: -
Identifier Source: org_study_id
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