Evaluation of the Effect of Laser Acupuncture on Myalgia and Arthralgia During Docetaxel or Paclitaxel Treatment in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- NRS on Day 3
研究概览
简要总结
This is a prospectively randomized and double-blinded clinical study. Cancer patients were suffered from the taxanes-induced joint pain, and would be advised to receive laser acupuncture in specific points to relieve pain. Clinical effects of analgesic changes would be evaluated before and after the intervention. The inflammation associated indices would be further analyzed to reveal the therapeutic mechanism of laser acupuncture. The laser acupuncture was expected to relief taxanes-induced adverse effects in patients and also can improve patients' life quality.
详细描述
The current clinical study is prospectively randomized and double-blinded, and practice in Chang Gung Memorial Hospital in Linkou, TaoYuan and Taipei branches. All 90 participants suffered from taxanes-induced myalgia and Arthralgia, and will be randomly assigned into the experimental groups (45 participants) and the control group (45 participants). The experiment group would arrange laser acupuncture on day1 and day3 after Taxanes treatment, besides the control group arrange pseudo-laser acupuncture. In the mean while, blood tests were performed with the C-Reactive protein, erythrocyte sedimentation rate, Interleukin-6 for each participants. Evaluation would be records on day1, day3, and day 8 after Taxanes treatment.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The investigators would put eye masking over participants. The care providers would not know the laser acupuncture device or pseudo-laser acupuncture device with randomization. The investigator did not know which group the participants belonged with.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patients received taxanes treatment and complained with myalgia and Arthralgia in the first taxanes treatment course.
- •Age between 20-70 years old
- •The NRS (numerical rating scale) score of pain increased more than 2 after the treatment.
- •Both 1st and 2nd taxanes treatment with the same dose
排除标准
- •Receiving acupuncture or herbal medicine over past three months
- •Myalgia and arthralgia were not due to taxanes treatment such osteoarthritis or rheumatic arthritis
- •Wounds or skin infections over laser acupuncture points
- •Refuse assign information consent or follow study protocol
结局指标
主要结局
NRS on Day 3
时间窗: Day 3 after Taxanes treatment
Numerical rating scale in pain evaluation
NRS on Day 1
时间窗: Day 1 after Taxanes treatment
Numerical rating scale in pain evaluation
NRS on Day 8
时间窗: Day 8 after Taxanes treatment
Numerical rating scale in pain evaluation
次要结局
- Functional Assessment of Cancer Therapy-General Scale on Day 1(Day 1)
- Inflammation assessment(Day 1 and day 3)
- Functional Assessment of Cancer Therapy-General Scale on Day 3(Day 3)
- Functional Assessment of Cancer Therapy-General Scale on Day 8(Day 8)