Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis

NCT06939582 | Recruiting Phase 1

• 1 other identifier: 20241413
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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

Conditions

Radiation-induced Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• the WHO grade of RIOM

  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

Study Arms (2)

Control group

PLACEBO COMPARATOR

use the placebo

Other: Placebo

trial group

EXPERIMENTAL

use the hydroxychloroquine sulfate tablets

Drug: Hydroxychloroquine Sulfate Tablets

Interventions

Hydroxychloroquine Sulfate Tablets DRUG

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

trial group

Placebo OTHER

the control group use the Placebo

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xingchen Peng: lead

Study Sites (1)

Department of Radiation Oncology

Chengdu, Sichuan, 610000, China

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Interventions

Hydroxychloroquine

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Peng xingchen Professor

CONTACT

+86 1880606753; pxx2014@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Radiation Oncology, Clinical Professor，West China Hospital

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 23, 2025
• Study Start: December 22, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 20, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)