Hydroxychloroquine Sulfate Tablets for Radiation-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

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

Treatments tested in this trial

  • Hydroxychloroquine Sulfate Tablets
  • Placebo

Treatment groups

158 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Xingchen Peng

Lead sponsor

West China Hospital

Sponsor institution