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end of the supporting fund
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser acupuncture group | Experimental | 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. |
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| Pseudo-laser acupuncture group | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser acupuncture device | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ChangGung Memorial Hospital | Taoyuan | 333 | Taiwan |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| D018771 | Arthralgia |
| D009369 | Neoplasms |
| D063806 | Myalgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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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.
|
| Pseudo-laser acupuncture | Device | 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. |
|
| 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 |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D059352 | Musculoskeletal Pain |