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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-13

Study Completion Date

2022-02-24

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.

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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.

Conditions

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Pain Cancer Joint Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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Laser acupuncture group

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.

Group Type EXPERIMENTAL

Laser acupuncture device

Intervention Type 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.

Pseudo-laser acupuncture group

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.

Group Type SHAM_COMPARATOR

Pseudo-laser acupuncture

Intervention Type 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.

Interventions

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Laser acupuncture 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.

Intervention Type DEVICE

Pseudo-laser acupuncture

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Cancer patients received taxanes treatment and complained with myalgia and Arthralgia in the first taxanes treatment course.
2. Age between 20-70 years old
3. The NRS (numerical rating scale) score of pain increased more than 2 after the treatment.
4. Both 1st and 2nd taxanes treatment with the same dose

Exclusion Criteria

1. Receiving acupuncture or herbal medicine over past three months
2. Myalgia and arthralgia were not due to taxanes treatment such osteoarthritis or rheumatic arthritis
3. Wounds or skin infections over laser acupuncture points
4. Refuse assign information consent or follow study protocol

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No