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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
175
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.
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.
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The incidence of Severe Oral mucositis (WHO grade ≥3)
Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Xerostomia
Patients self-rated xerostomia according to summated xerostomia inventory (SXI), and researchers measured saliva flow rates.
Time frame: 1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks); and 1, 3, 6, 9 and 12 months after the end of radiotherapy
Patients' quality of life assessment of EORTC QLQ-C30 and H&N35 questionnaires.
EORTC QLQ-C30 and H\&N35 questionnaires
Time frame: 1 week before radiotherapy; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks); ; and 1, 3, 6, 9 and 12 months after the end of radiotherapy
Adverse events
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version
Time frame: From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks
Mouth and throat soreness (MTS) scores
Patients report mouth and throat soreness (MTS) scores (Likert scale 1 to 5) via the oral mucositis weekly questionnaire （OMWQ）. Higher score indicates more severe symptoms.
Time frame: The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6 1/2 weeks
The duration of Severe Oral mucositis (WHO grade ≥3)
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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.
The first determination of SOM to the first instance of non-severe OM (WHO grade \<3), without a subsequent instance of SOM. Patients without observed SOM were assigned a duration of 0 days.
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
The time to onset of Severe Oral mucositis (WHO grade ≥3)
Time from the first day of radiotherapy to the first determination of SOM. Patients without observed SOM were assigned onset days of 6 or 6.5 weeks.
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Taste function
Patients self-rated dysgeusia, Electrogustometer test and taste strips test.
Time frame: 1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks); and 1, 3, 6, 9 and 12 months after the end of radiotherapy