Detecting Changes Before and After Chemotherapy or Radiotherapy in Patients With Head and Neck Cancer by Meridian Electroacupuncture Analysis Device (MEAD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- meridian energy
研究概览
简要总结
This trial is conducted by using MEAD to detect the meridian changes in patients with head and neck cancer after conventional treatment of chemotherapy or radiotherapy.
详细描述
The purpose of this research is observe the change of meridian energy in patients have be diagnosed with head and neck cancer. The instrument we use is a non-invasive device called meridian energy analysis device(MEAD). The theory of MEAD is use conductive rod to measure the skin resistance from the specific point in human body, and to calculate the meridian's energy change. In Traditional Chinese Medicine theory, physician doctor believe that the median in human body would be affected by disease or uncomfortable condition. So, this time, we who a group of physician of Traditional Chinese medicine department conduct this research to assess the energy change in patients with head and neck cancer. The trail cooperate with radiation oncology department and hematology oncology department. Subject enrollment from radiation oncology department and hematology Oncology department. All of subjects have be diagnosed with head and neck cancer, and will to receive conventional treatment, no matter chemotherapy or/and radiotherapy.
The major assessment of our research is meridian energy by MEAD before treatment, and six consecutive cycles. In addition to this, pain degree, oral mucositis condition, impact on life quality, and blood test, diagnosis imaging data will be collected.
According to G*Power( 3.1.9.4 edition), we expected to recruit 34 subjects. All of Statistical Analysis will use SPSS, pair-t test is used to analyze continuous variable, categorical variable will be analyzed by Chi-Square Test. Multivariate regression analysis will be apply to discuss the major factor of the meridian changes.
MEAD is a kind of non-invasive device, hasn't had adverse effect until now. We will start emergency handling If accidents happened within measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with head and neck cancer, included nasopharyngeal carcinoma, laryngeal cancer, oropharyngeal cancer, ear and oral cancer, hypopharyngeal cancer, salivary-gland carcinoma. Aged between 20 years old to 75years old, no gender difference.
- •patients with head and neck cancer has not received surgery yet, and will plan to accept chemotherapy and/or radiotherapy.
- •recurrent head and neck cancer, and expect to received chemotherapy and/or radiotherapy.
- •patient with vital sings stableness, conscious clear, and have ability to recognize the contain of trail and sign consent.
- •not accept other adjuvant therapy.
- •no brain metastasis or psychosis, and will to join whole course as well as accept assessments.
排除标准
- •Aged less than 20 years old and over 75 years old。
- •Patients be diagnosed with head and neck cancer, and accepted surgery, or already finished chemotherapy and/or radiotherapy.
- •patient with brain metastasis, conscious unclear, and have not able to recognize the contain of trail and sign consent.
- •Accept other adjuvant therapy and chemotherapy and/or radiotherapy simultaneously.
- •Combined with serious organs failure。
- •Have contraindication in chemotherapy or radiotherapy.
结局指标
主要结局
meridian energy
时间窗: An average of 6 weeks
energy change in meridian
次要结局
- pain degree(An average of 6 weeks)
- Oral mucositis grading(An average of 6 weeks)
- the number of participants with blood test data abnormal(An average of 6 weeks)
- adverse impact on quality of life(An average of 6 weeks)
- imaging diagnosis(An average of 6 weeks)
研究者
Liao Jian An
Attending physician of Traditional Chinese Medicine department
Chang Gung Memorial Hospital