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

Overview

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 Title of Study: “Evaluation of the Effect of Laser Acupuncture on Myalgia and Arthralgia During Docetaxel or Paclitaxel Treatment in Cancer Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: May 30, 2021

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.

Interventions

  • Device: 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Sham Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • NRS on Day 1
    • Time Frame: Day 1 after Taxanes treatment
    • Numerical rating scale in pain evaluation
  • NRS on Day 3
    • Time Frame: Day 3 after Taxanes treatment
    • Numerical rating scale in pain evaluation
  • NRS on Day 8
    • Time Frame: Day 8 after Taxanes treatment
    • Numerical rating scale in pain evaluation

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chang Gung Memorial Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Shao-Wen Yu, MD, +886975366326, romantic1225@gmail.com

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