NCT01876407Unknown4 期
Effectiveness of Low Energy Laser Treatment in Oral Mucositis Induced by Chemotherapy and Radiotherapy in Head and Neck Cancer
Fundación Pública Andaluza Progreso y Salud1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2013年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Evaluate the effectiveness of using low-intensity laser compared with placebo as preventive and therapeutic intervention of oral mucositis induced by radiation therapy and chemotherapy.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of using to low intensity laser as an intervention against preventive and therapeutic oral mucositis induced by radiotherapy and chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 diagnosed with squamous cell carcinoma of the oral cavity.
- •Patients aged between 18 and 80 years.
- •Patients who are to receive one of the following treatment
- •Combined radiotherapy (conventional fractionation 70 Gy reaching the tumor and affected lymph nodes, and 50 Gy in the areas ganglion drainage) and chemotherapy (cisplatin 100 mg/m2 IV on days 1, 22 and 43 irradiation or cetuximab 400mg/m2 as a single dose pre-load radiotherapy and 250mg/m2 weekly for the same. Regardless of whether they have received previous surgical treatment.
- •Treatment with radiotherapy of 70 Gy in 35 daily sessions 2Gy/día consecutive.
- •Patients who voluntarily express their intention to participate by informed consent.
排除标准
- •Patients who denied informed consent.
- •Patients who have hypersensitivity or allergy to any of the components included in the study.
- •Patients diagnosed with HIV, and autoimmune diseases.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Low intensity laser for oral mucositis switch off (Device)
Low energy laser
Experimental
Administration of a low energy laser for oral mucositis.
干预措施: Low intensity laser for oral mucositis (Device)
结局指标
主要结局
Evaluate the effectiveness of using low-intensity laser compared with placebo as preventive and therapeutic intervention of oral mucositis induced by radiation therapy and chemotherapy.
时间窗: 24 months
次要结局
- Evaluate the effectiveness of using low level laser compared with placebo in analgesic use during and after cancer treatment.(24 months)
- Evaluate the effectiveness of using low level laser compared with placebo in reducing pain during and after cancer treatment.(24 months)
- Evaluate the effectiveness of using low level laser compared with placebo in the prevention of onset of oral mucositis induced by treatment of head and neck QRT.(24 months)
- Assess the intervention tolerance and side effects of it.(24 months)
- Evaluate the effectiveness of the use of low laser intensity versus placebo in improving the healing of oral mucositis induced by treatment of head and neck QRT.(24 months)
研究者
研究点 (1)
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