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NCT Number: NCT06939582

Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis

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

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Key information

Conditions

Radiation-induced Oral Mucositis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Radiation Oncology

Chengdu, Sichuan, 610000, China

Location status: Recruiting

Location contact

Professor, Xingchen Peng

CONTACT

[email protected]

18980754549

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroxychloroquine Sulfate Tablets

Drug

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

Placebo

Other

the control group use the Placebo

Primary outcomes

  1. the WHO grade of RIOM

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Peng xingchen Professor

CONTACT

[email protected]

+86 1880606753

Sponsors and collaborators

Lead sponsor

Xingchen Peng

Other

Registry information

Official study 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

Acronym: RIOM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 23, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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