Meridian Yoga on Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Neuropathic Pain Scale
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in breast cancer patients with completion of chemotherapy, and that is characterized by associated clinical symptoms such as pain, tingling, numbness, and paresthesia etc. CIPN also interferes with patients' functions of daily living and leads to chronic functional decline and a reduced quality of life. Meridian yoga is beneficial to the treatment of patients with peripheral neuropathy and the improvement of their quality of life.
详细描述
Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in breast cancer patients with completion of chemotherapy, and that is characterized by associated clinical symptoms such as pain, tingling, numbness, and paresthesia etc. CIPN also interferes with patients' functions of daily living and leads to chronic functional decline and a reduced quality of life. Meridian yoga is beneficial to the treatment of patients with peripheral neuropathy and the improvement of their quality of life.
Therefore, the aim of this study was to evaluate the efficacy of meridian yoga for CIPN in breast cancer patients. The investigators designed a clinical randomized controlled trial in which 80 patients with CIPN were equally divided into a control group (8 weeks of general care) and a treatment group (general care plus 16 times yoga interventions for 8 weeks). The assessment time was before (vision 1) and at the completion of 8 weeks of Meridian yoga treatment (vision 2). The primary outcome was the change in scores of the neuropathic pain scale (Chinese version). The secondary outcome was to the changes of meridian energy [Meridian Energy Analyzer (M.E.A.D.)], Perfusion Index (PI) value of peripheral blood flow, and the changes of cortisol and IL-6 level in salivary fluid.
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
- Double (Investigator, Outcomes Assessor)
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
- •Chinese or Taiwanese-proficient men and women aged ≥18 years.
- •Patients with stage I-III breast cancer.
- •Suffering from peripheral neuropathy caused by chemotherapy (professional judgment by a physician).
- •Willing to adhere to requirement that no new pain medication be taken throughout the study period.
- •Willing to adhere to all study-related procedures, including randomization to one of the two arms.
- •Patient answers "Yes" to at least one factor in the question: "Do participants think your balance, gait, posture, alignment, or flexibility has been affected by your experience of CIPN?"
排除标准
- •Metastatic disease.
- •Drugs abuse such as amphetamines, morphine, etc.
- •Those with severe mental illness or mental instability who cannot cooperate with the trial.
- •People who are severely hearing impaired, visually impaired, or demented and unable to perform yoga.
- •Severe heart disease or chronic obstructive lung disease, liver or kidney failure,and edema or severe skin damage.
- •Severe spinal disease, affecting actors.
- •Those who have participated in yoga practice in the past month.
- •Those who do not sign the informed consent.
结局指标
主要结局
Neuropathic Pain Scale
时间窗: Change from baseline of Neuropathic Pain Scale at 8 weeks.
The questionnaire explores the performance of patients with neuropathic pain and nociceptive pain in different pain types in this questionnaire, and has appropriate reliability and validity, among which, specific pain performance, for different types of pain and changes in nerve conduction examination have special performance. This questionnaire is NPSI-T(Chinese version of neuropathic pain symptom inventory). It consists of 12 questions, all of which address pain on a scale of 0-10. Higher scores mean a worse outcome.
次要结局
- Peripheral perfusion index(Change from baseline Peripheral perfusion index at 8 weeks.)