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A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy
Sponsor: West China Hospital
Summary
To evaluate the efficacy and safety of lithium-containing mouthwash for prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy for malignant head and neck tumors.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
175
Start Date
2024-03-01
Completion Date
2025-05-01
Last Updated
2026-08-13
Healthy Volunteers
No
Interventions
lithium-containing mouthwash （Phase I）
The main ingredients of lithium-containing mouthwash are lithium carbonate and citric acid. A total of 5 concentration gradients of lithium-containing mouthwash are set, including 0.03, 0.06, 0.10, 0.15 and 0.30 mol/L. Mouthwash is used to gargle and left in the mouth for 5 min to be spat out three times a day from the first day of radiotherapy up to the end of treatment.
Plcacebo mouthwash （Phase II）
Placebo Mouthwash is mainly composed of citric acid and sodium hydroxide, transparent colorless liquid. Mouthwash is used to gargle and left in the mouth for 5 min to be spat out three times a day from the first day of radiotherapy up to the end of treatment.
lithium-containing mouthwash（Phase II）
Effective lithium salt concentrations screened in the Phase I trial is used as active interventions in this group of interventions. Mouthwash is used to gargle and left in the mouth for 5 min to be spat out three times a day from the first day of radiotherapy up to the end of treatment.
Locations (1)
West China Hospital, Sichuan University
Chengdu, Sichuan, China