Effectiveness of Different Mouthwash Temperatures on Oral Mucositis Pain and Patient Comfort During Radiotherapy for Head and Neck Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain Intensity (VAS 0-10)
研究概览
简要总结
This single-center randomized controlled trial evaluates the effects of cold (15-20°C) versus room-temperature (30-35°C) water gargling on oral mucositis severity, pain, and comfort in patients with head and neck cancer undergoing radiotherapy. Participants will rinse their mouth four times daily for 30-60 seconds over a 6-week radiotherapy course, with follow-up for two additional weeks. The study hypothesizes that cold-water rinsing can reduce the severity of radiation-induced oral mucositis (RTOM) and pain, improve oral comfort, and minimize treatment interruptions.
详细描述
Radiation-induced oral mucositis (RTOM) is a frequent and debilitating side effect of radiotherapy for head and neck cancer, leading to pain, nutritional compromise, and potential treatment discontinuation. Cryotherapy and local temperature modulation have been proposed as low-cost, accessible nursing interventions that reduce inflammation through vasoconstriction and analgesia. This randomized trial will assess the clinical efficacy and patient acceptability of temperature-modulated water rinsing as a non-pharmacologic, supportive-care intervention. Subgroup analyses will examine differential responses among patients with dental sensitivity or betel-nut chewing habits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed head and neck cancer (HNC) receiving radiotherapy for the first time, with or without concurrent chemotherapy.
- •Conscious, communicative, and able to perform the rinsing procedure and complete questionnaires.
- •Provided written informed consent prior to enrollment.
排除标准
- •Non-HNC diagnoses or radiotherapy to sites outside the oral/oropharyngeal region.
- •Cognitive impairment or inability to complete the rinsing protocol.
结局指标
主要结局
Pain Intensity (VAS 0-10)
时间窗: Baseline (prior to radiotherapy), Weeks 1-6 during radiotherapy, and 2 weeks after completion of radiotherapy
Patient-reported pain intensity using VAS (0-10).
Oral Mucositis Severity
时间窗: Baseline (prior to radiotherapy), Week 2, Week 4, Week 6 (end of radiotherapy), and 2 weeks after completion of radiotherapy
Assessed using WHO Oral Mucositis Grading Scale (0-4).
次要结局
- Oral Comfort(Baseline, Week 2, Week 4, Week 6 (end of radiotherapy))
- Psychological Distress(Baseline (prior to radiotherapy) and Week 6 (end of radiotherapy))
- Satisfaction with Rinsing Modality(Week 6 (end of radiotherapy) and 2 weeks after completion of radiotherapy)