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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06939582

Acronym

RIOM

Enrollment

158

Registered

2025-04-23

Start date

2024-12-22

Completion date

2025-06-20

Last updated

2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation-induced Oral Mucositis

Brief summary

Evaluate the safety, tolerance and efficacy of hydroxychloroquine sulfate tablets the prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy

Interventions

DRUGHydroxychloroquine Sulfate Tablets

the trial group use the hydroxychloroquine sulfate tablets (200mg/time, bid)

OTHERPlacebo

the control group use the Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
the WHO grade of RIOM	From the start of radiotherapy to 8 weeks after completion of radiotherapy	use the WHO Oral Toxicity Scale to evaluate the WHO grade of RIOM. WHO O grade: no representation of RIOM; WHO 1 grade: soreness and erythema; WHO 2 grade: erythema, ulcers and ability to eat solids; WHO 3 grade: ulcers, requiring liquid diet; WHO 4 grade: alimentation not possible. The higher scores mean a worse outcome.

Countries

China

Contacts

Primary ContactPeng xingchen Professor

pxx2014@scu.edu.cn+86 1880606753

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026