A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy
- Conditions
- Malignant Head and Neck TumorsHead and Neck Squamous Cell Carcinoma
- Interventions
- Drug: lithium-containing mouthwashDrug: Plcacebo mouthwash
- Registration Number
- NCT06251050
- Lead Sponsor
- West China Hospital
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
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.
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.30 mol/L lithium mouthwash lithium-containing mouthwash 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. Lithium mouthwash lithium-containing mouthwash Effective lithium salt concentrations screened in the Phase I trial is used as active interventions in this group of interventions. Placebo mouthwash Plcacebo mouthwash Placebo Mouthwash is mainly composed of citric acid and sodium hydroxide, transparent colorless liquid.
- Primary Outcome Measures
Name Time Method The incidence of Severe Oral mucositis (WHO grade ≥3) From the start of radiotherapy to 8 weeks after completion of radiotherapy Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.
- Secondary Outcome Measures
Name Time Method Xerostomia 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 self-rated xerostomia according to summated xerostomia inventory (SXI), and researchers measured saliva flow rates.
Patients' quality of life assessment of EORTC QLQ-C30 and H&N35 questionnaires. 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 EORTC QLQ-C30 and H\&N35 questionnaires
Adverse events From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version
Mouth and throat soreness (MTS) scores 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 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.
The duration of Severe Oral mucositis (WHO grade ≥3) From the start of radiotherapy to 8 weeks after completion of radiotherapy 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.
The time to onset of Severe Oral mucositis (WHO grade ≥3) From the start of radiotherapy to 8 weeks after completion of radiotherapy 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.
Taste function 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 self-rated dysgeusia, Electrogustometer test and taste strips test.
Trial Locations
- Locations (1)
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China