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
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Xingchen Peng
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- the WHO grade of RIOM
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control group
use the placebo
Intervention: Placebo (Other)
trial group
use the hydroxychloroquine sulfate tablets
Intervention: Hydroxychloroquine Sulfate Tablets (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Xingchen Peng
Department of Radiation Oncology, Clinical Professor，West China Hospital
West China Hospital