Hydroxychloroquine Sulfate Tablets for Radiation-induced Oral Mucositis

ConditionRadiation-induced Oral Mucositis

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorXingchen Peng

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Hydroxychloroquine Sulfate Tablets
Drug
the trial group use the hydroxychloroquine sulfate tablets (200mg/time, bid)
Placebo
Other intervention
the control group use the Placebo

Treatment groups

158 Participants

are divided into 2 treatment groups

Group A: Control groupPlacebo comparator 1 intervention

Group B: trial groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

From the start of radiotherapy to 8 weeks after completion of radiotherapy

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xingchen Peng

Lead sponsor

West China Hospital

Sponsor institution

Source ClinicalTrials.gov

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