Related Experiment Video
Updated: Aug 23, 2026
Intramucosal Inoculation of Squamous Cell Carcinoma Cells in Mice for Tumor Immune Profiling and Treatment Response Assessment
Published on: April 22, 2019
Effect of Lithium Mouthwash on Oral Mucositis and Taste Dysfunction in Head and Neck Radiation Therapy: The Phase 1/2
Zixia Li1, Yiyan Pei2, Zhiying Zhang1
1Department of Cariology and Endodontics, National Clinical Research Center for Oral Diseases, State Key Laboratory of Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, People's Republic of China.
Purpose:
Oral mucositis (OM) and taste dysfunction (TD) are common oral complications of radiation therapy (RT) in patients with head and neck cancer, significantly impairing treatment outcomes and quality of life. The purpose of this study was to evaluate the effectiveness and safety of a lithium-containing mouthwash for managing OM and to explore its potential protective effect against TD.
Methods And Materials:
This prospective single-institutional phase 1/2 trial enrolled patients with head and neck cancer undergoing definitive or postoperative adjuvant RT. Patients received a lithium-containing mouthwash or placebo 3 times daily during RT. The phase 1 study assessed its dose-limiting toxicity and determined the dose for phase 2. The primary endpoint in phase 2 was the incidence of severe OM (SOM). Secondary endpoints included time to onset and duration of SOM, taste alteration, incidence of dry mouth, quality of life, and safety.
Results:
A total of 175 patients were enrolled: 15 in phase 1 and 160 in phase 2. Based on phase 1 results, phase 2 used a 0.15 mol/L lithium-containing mouthwash. In phase 2, the incidence of SOM was significantly lower in the lithium group than in the placebo group (34.2% vs 52.1%; P = .0304). The time to onset of SOM (median not estimable vs 35.0 days; P = .0262) was also shorter in the lithium group. Additionally, the lithium-containing mouthwash reduced TD during RT. Adverse events were similar between groups, and no severe lithium-related adverse events were observed.
Conclusions:
Lithium-containing mouthwash significantly reduced the incidence and time to onset of SOM, had a good safety profile, and showed potential to ameliorate irradiation-induced TD.
