Acupuncture as the Therapeutic Modalities of Acute Toxicity in the Radiotherapy of Head and Neck Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy
研究概览
简要总结
The aim of the study is to evaluate the benefit of the acupuncture as healing modalities in the therapy of acute toxicity of radiotherapy.
详细描述
The study will enroll 100 patients in current radiotherapy of the head and neck cancer with acute radiotoxic symptoms at least of G1. The patients will be randomized (by ticket) in two regimens 1:1.
Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.
Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.
Due to the disease and patients differences, treatment will be individualized. Used acupuncture points will be documented. The patients difficulties will be observed and their medication and will be recorded in the patient diary.
Possible skin toxicities wil be documented by the photography.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Curative and adjuvant radiotherapy for head and neck tumors;
- •Patient collaboration in evaluation of the toxicity diary.
排除标准
- •Palliative radiotherapy in the head and neck tumor;
- •Non-compliance of the patient.
研究组 & 干预措施
Regimen A
Regimen A (control regimen): standard support treatment of adverse events of the radiotherapy.
干预措施: Standard supportive therapy (Drug)
Regimen B
Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.
干预措施: Acupuncture (Other)
Regimen B
Regimen B (acupuncture regimen): standard support treatment of adverse events of the radiotherapy and acupuncture.
干预措施: Standard supportive therapy (Drug)
结局指标
主要结局
Management of acute toxicity of radiotherapy with acupuncture: Reducing the grade of acute toxicity in radiotherapy
时间窗: six months after the end of radiotherapy
Reducing the grade of acute toxicity in radiotherapy.
次要结局
- Management of chronic toxicity of radiotherapy with acupuncture: Lower incidence of chronic toxicity of radiotherapy(six months after the end of radiotherapy)