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

Sichuan University

Status and phase

Completed

Phase 2

Phase 1

Conditions

Malignant Head and Neck Tumors

Head and Neck Squamous Cell Carcinoma

Treatments

Drug: lithium-containing mouthwash

Drug: Plcacebo mouthwash

Study type

Interventional

Funder types

Other

Identifiers

NCT06251050

2023-863

Details and patient eligibility

About

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.

Full description

The goal of this clinical trial is to evaluate the efficacy and safety of lithium-containing mouthwash in reducing the incidence, duration, and severity of severe oral mucositis (SOM) , and the incidence of dysgeusia. The main questions it aims to answer are whether lithium-containing mouthwash can effectively prevent and treat radiation-induced oral mucositis and dysgeusia, and whether it will cause adverse events in patients undergoing radiotherapy.

Participants will be instructed to use lithium-containing mouthwash or placebo mouthwash three times daily from the beginning to the end of RT.

Researchers will compare lithium-containing mouthwash group and placebo group to see if lithium-containing mouthwash are beneficial in preventing and treating oral mucositis and dysgeusia in patients undergoing radiotherapy.

Enrollment

175 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Known to be allergic to lithium or other components of mouthwash or severe allergic constitution; Poor oral hygiene and/or severe periodontal diseases; Any previous RT to the head and neck region, Severe kidney disease, severe cardiovascular disease, myasthenia gravis, Parkinson's disease or epilepsy; Recent use or current use of diuretics or other drugs known to interact with lithium; Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

175 participants in 7 patient groups, including a placebo group

0.03 mol/L lithium mouthwash

Experimental group

Description:

The main ingredients of mouthwash are lithium carbonate and citric acid, transparent colorless liquid. In this group, 10 ml of 0.03 mol/L lithium mouthwash is used to gargle and left in the mouth for 5 min to be spat out from the first day of radiotherapy up to the end of treatment.

0.06 mol/L lithium mouthwash

Experimental group

Description:

The main ingredients of mouthwash are lithium carbonate and citric acid, transparent colorless liquid.. In this group, 10 ml of 0.06 mol/L lithium mouthwash is used to gargle and left in the mouth for 5 min to be spat out from the first day of radiotherapy up to the end of treatment.

0.10 mol/L lithium mouthwash

Experimental group

Description:

The main ingredients of mouthwash are lithium carbonate and citric acid,transparent colorless liquid. In this group, 10 ml of 0.10 mol/L lithium mouthwash is used to gargle and left in the mouth for 5 min to be spat out from the first day of radiotherapy up to the end of treatment.

0.15 mol/L lithium mouthwash

Experimental group

Description:

The main ingredients of mouthwash are lithium carbonate and citric acid, transparent colorless liquid. In this group, 10 ml of 0.15 mol/L lithium mouthwash is used to gargle and left in the mouth for 5 min to be spat out from the first day of radiotherapy up to the end of treatment.

0.30 mol/L lithium mouthwash

Experimental group

Description:

The main ingredients of mouthwash are lithium carbonate and citric acid, transparent colorless liquid. In this group, 10 ml of 0.30 mol/L lithium mouthwash is used to gargle and left in the mouth for 5 min to be spat out from the first day of radiotherapy up to the end of treatment.

Treatment:

Drug: lithium-containing mouthwash

Lithium mouthwash

Active Comparator group

Description:

Effective lithium salt concentrations screened in the Phase I trial is used as active interventions in this group of interventions.

Treatment:

Drug: lithium-containing mouthwash

Placebo mouthwash

Placebo Comparator group

Description:

Placebo Mouthwash is mainly composed of citric acid and sodium hydroxide, transparent colorless liquid.