A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

175

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

March 1, 2025

Study Completion Date

May 1, 2025

Conditions
Head and Neck Squamous Cell CarcinomaMalignant Head and Neck Tumors
Interventions
DRUG

lithium-containing mouthwash

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.

DRUG

Plcacebo mouthwash

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.

DRUG

lithium-containing mouthwash

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.

Trial Locations (1)

610041

West China Hospital, Sichuan University, Chengdu

All Listed Sponsors
lead

West China Hospital

OTHER

NCT06251050 - A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy | Biotech Hunter | Biotech Hunter