Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis (RIOM)

April 26, 2025 updated by: Xingchen Peng

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

158

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Department of Radiation Oncology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
use the placebo
Other: Placebo
the control group use the Placebo
Experimental: trial group
use the hydroxychloroquine sulfate tablets
Drug: Hydroxychloroquine Sulfate Tablets
the trial group use the hydroxychloroquine sulfate tablets (200mg/time, bid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the start of radiotherapy to 8 weeks after completion of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xingchen Peng

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 20, 2025

Study Registration Dates

First Submitted

April 20, 2025

First Submitted That Met QC Criteria

April 20, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 26, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20241413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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