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

Not Applicable

Terminated

• Conditions: Pain Cancer; Joint Pain
• Interventions: Device: Laser acupuncture device; Device: Pseudo-laser acupuncture

• Registration Number: NCT04872556
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-04
• Study Start: 2021-05-13
• Primary Completion: 2021-12-31
• Study Completion: 2022-02-24
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser acupuncture group	Laser acupuncture device	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.
Pseudo-laser acupuncture group	Pseudo-laser acupuncture	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.

Primary Outcome Measures

Name	Time	Method
NRS on Day 8	Day 8 after Taxanes treatment	Numerical rating scale in pain evaluation
NRS on Day 1	Day 1 after Taxanes treatment	Numerical rating scale in pain evaluation
NRS on Day 3	Day 3 after Taxanes treatment	Numerical rating scale in pain evaluation

Secondary Outcome Measures

Name	Time	Method
Inflammation assessment	Day 1 and day 3	Inflammation associated indices: Interleukin-6
Functional Assessment of Cancer Therapy-General Scale on Day 1	Day 1	A Taxanes treatment questionnaire
Functional Assessment of Cancer Therapy-General Scale on Day 3	Day 3	A Taxanes treatment questionnaire
Functional Assessment of Cancer Therapy-General Scale on Day 8	Day 8	A Taxanes treatment questionnaire

Trial Locations

Locations (1)

ChangGung Memorial Hospital; 🇨🇳 TaoYuan, Taiwan