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

Primary Purpose

Pain Cancer, Joint Pain

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Laser acupuncture device
Pseudo-laser acupuncture
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Cancer focused on measuring Laser acupuncture, Taxanes, Chemotherapy, Cancer, Myalgia, Arthralgia

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • ChangGung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Laser acupuncture group

Pseudo-laser acupuncture group

Arm 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.

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.

Outcomes

Primary Outcome Measures

NRS on Day 1
Numerical rating scale in pain evaluation
NRS on Day 3
Numerical rating scale in pain evaluation
NRS on Day 8
Numerical rating scale in pain evaluation

Secondary Outcome Measures

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

Full Information

First Posted
April 21, 2021
Last Updated
July 29, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04872556
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 13, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
February 24, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Cancer, Joint Pain
Keywords
Laser acupuncture, Taxanes, Chemotherapy, Cancer, Myalgia, Arthralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser acupuncture group
Arm Type
Experimental
Arm 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.
Arm Title
Pseudo-laser acupuncture group
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Laser acupuncture device
Intervention Description
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
Intervention Name(s)
Pseudo-laser acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
NRS on Day 1
Description
Numerical rating scale in pain evaluation
Time Frame
Day 1 after Taxanes treatment
Title
NRS on Day 3
Description
Numerical rating scale in pain evaluation
Time Frame
Day 3 after Taxanes treatment
Title
NRS on Day 8
Description
Numerical rating scale in pain evaluation
Time Frame
Day 8 after Taxanes treatment
Secondary Outcome Measure Information:
Title
Inflammation assessment
Description
Inflammation associated indices: C-Reactive protein
Time Frame
Day 1 and day 3
Title
Inflammation assessment
Description
Inflammation associated indices: erythrocyte sedimentation rate
Time Frame
Day 1 and day 3
Title
Inflammation assessment
Description
Inflammation associated indices: Interleukin-6
Time Frame
Day 1 and day 3
Title
Functional Assessment of Cancer Therapy-General Scale on Day 1
Description
A Taxanes treatment questionnaire
Time Frame
Day 1
Title
Functional Assessment of Cancer Therapy-General Scale on Day 3
Description
A Taxanes treatment questionnaire
Time Frame
Day 3
Title
Functional Assessment of Cancer Therapy-General Scale on Day 8
Description
A Taxanes treatment questionnaire
Time Frame
Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cancer patients received taxanes treatment and complained with myalgia and Arthralgia in the first taxanes treatment course. Age between 20-70 years old The NRS (numerical rating scale) score of pain increased more than 2 after the treatment. Both 1st and 2nd taxanes treatment with the same dose Exclusion Criteria: Receiving acupuncture or herbal medicine over past three months Myalgia and arthralgia were not due to taxanes treatment such osteoarthritis or rheumatic arthritis Wounds or skin infections over laser acupuncture points Refuse assign information consent or follow study protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shao-Wen Yu, MD
Phone
+886975366326
Email
romantic1225@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sung-han Lin, PhD
Phone
+886911112025
Email
image.lin@gmail.com
Facility Information:
Facility Name
ChangGung Memorial Hospital
City
TaoYuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ShaoWen Yu, Dr.
Phone
+886975366326
Email
romantic1225@gmail.com

12. IPD Sharing Statement

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

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