Evaluation of the Effect of Laser Acupuncture on Taxane Acute Pain Syndrome Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Effect of Laser Acupuncture on Myalgia and Arthralgia During Docetaxel or Paclitaxel Treatment in Cancer Patients

Conditions
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Pain Cancer, Joint Pain

Intervention / Treatment
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* Device: Laser acupuncture device
* Device: Pseudo-laser acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants would be 90 cancer patients accepted Taxanes treatment who are suffered from myalgia and Arthralgia. The investigators would put 45 participants in experimental groups and the other 45 participants in control group with randomization.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser acupuncture group<br>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. | Device: Laser acupuncture device<br>* The experiment group would arrange laser acupuncture on day1 and day3 after Taxanes treatment. 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.<br>|
| Sham Comparator: Pseudo-laser acupuncture group<br>The experiment group would arrange laser acupuncture on day1 and day 3 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. | Device: Pseudo-laser acupuncture<br>* The experiment group would arrange Pseudo-laser acupuncture on day1 and day3 after Taxanes treatment. 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS on Day 1 | Numerical rating scale in pain evaluation | Day 1 after Taxanes treatment | 
| NRS on Day 3 | Numerical rating scale in pain evaluation | Day 3 after Taxanes treatment | 
| NRS on Day 8 | Numerical rating scale in pain evaluation | Day 8 after Taxanes treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation assessment | Inflammation associated indices: C-Reactive protein | Day 1 and day 3 | 
| Inflammation assessment | Inflammation associated indices: erythrocyte sedimentation rate | Day 1 and day 3 | 
| Inflammation assessment | Inflammation associated indices: Interleukin-6 | Day 1 and day 3 | 
| Functional Assessment of Cancer Therapy-General Scale on Day 1 | A Taxanes treatment questionnaire | Day 1 | 
| Functional Assessment of Cancer Therapy-General Scale on Day 3 | A Taxanes treatment questionnaire | Day 3 | 
| Functional Assessment of Cancer Therapy-General Scale on Day 8 | A Taxanes treatment questionnaire | Day 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser acupuncture, Taxanes, Chemotherapy, Cancer, Myalgia, Arthralgia