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

Chang Gung Medical Foundation

Status: Terminated

Conditions: Pain Cancer; Joint Pain

Treatments: Device: Pseudo-laser acupuncture; Device: Laser acupuncture device

Study type: Interventional

Funder types: Other

Identifiers

NCT04872556

202001710A3

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 2 patient groups

Laser acupuncture group

Experimental group

Description:

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.

Treatment:

Device: Laser acupuncture device

Pseudo-laser acupuncture group

Sham Comparator group

Description:

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.

Treatment:

Device: Pseudo-laser acupuncture