Clinical trial NCT04872556: Evaluation of the Effect of Laser Acupuncture on Taxane Acute Pain Syndrome Patients
Official title: Evaluation of the Effect of Laser Acupuncture on Myalgia and Arthralgia During Docetaxel or Paclitaxel Treatment in Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain Cancer
Joint Pain
Keywords: Laser acupuncture
Taxanes
Chemotherapy
Cancer
Myalgia
Arthralgia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: NRS on Day 1
timeFrame: Day 1 after Taxanes treatment
measure: NRS on Day 3
timeFrame: Day 3 after Taxanes treatment
measure: NRS on Day 8
timeFrame: Day 8 after Taxanes treatment
Secondary outcomes:
measure: Inflammation assessment
timeFrame: Day 1 and day 3
measure: Inflammation assessment
timeFrame: Day 1 and day 3
measure: Inflammation assessment
timeFrame: Day 1 and day 3
measure: Functional Assessment of Cancer Therapy-General Scale on Day 1
timeFrame: Day 1
measure: Functional Assessment of Cancer Therapy-General Scale on Day 3
timeFrame: Day 3
measure: Functional Assessment of Cancer Therapy-General Scale on Day 8
timeFrame: Day 8
Other outcomes:
Locations:
city: TaoYuan
country: Taiwan
facility: ChangGung Memorial Hospital
Study officials:
References: