A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- The incidence of Severe Oral mucositis (WHO grade ≥3)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
lithium-containing mouthwash （Phase I ）
Phase I consists of 5 cohorts of 3-6 patients each, with all patients enrolled sequentially. Patients receive 0.03, 0.06, 0.10, 0.15, and 0.30 mol/L of lithium-containing mouthwash, respectively. In this phase, patients are instructed to use 10 mL of lithium mouthwash to gargle and retain it in the mouth for 5 minutes before spitting it out, from the first day of radiotherapy until the end of treatment.
干预措施: lithium-containing mouthwash （Phase I） (Drug)
lithium-containing mouthwash （Phase II ）
Phase II is a randomized, placebo-controlled trial. All patients are randomly assigned to the experimental group or the placebo group. The lithium concentration in the mouthwash used in the experimental group is the effective concentration identified in Phase I, whereas the placebo group receives a mouthwash formulation without lithium salts. From the first day of radiotherapy until the end of treatment, patients use 10 mL of lithium mouthwash or placebo mouthwash to gargle and retain it in the mouth for 5 minutes before spitting it out.
干预措施: Plcacebo mouthwash （Phase II） (Drug)
lithium-containing mouthwash （Phase II ）
Phase II is a randomized, placebo-controlled trial. All patients are randomly assigned to the experimental group or the placebo group. The lithium concentration in the mouthwash used in the experimental group is the effective concentration identified in Phase I, whereas the placebo group receives a mouthwash formulation without lithium salts. From the first day of radiotherapy until the end of treatment, patients use 10 mL of lithium mouthwash or placebo mouthwash to gargle and retain it in the mouth for 5 minutes before spitting it out.
干预措施: lithium-containing mouthwash（Phase II） (Drug)
结局指标
主要结局
The incidence of Severe Oral mucositis (WHO grade ≥3)
时间窗: 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.
次要结局
- 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' 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)
- Adverse events(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(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)(From the start of radiotherapy to 8 weeks after completion of radiotherapy)
- The time to onset of Severe Oral mucositis (WHO grade ≥3)(From the start of radiotherapy to 8 weeks after completion of radiotherapy)
- 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)
研究者
Xingchen Peng
professor
West China Hospital