Joint Pain, Pain Cancer
Conditions
Keywords
Laser acupuncture, Taxanes, Chemotherapy, Cancer, Myalgia, Arthralgia
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.
Interventions
DEVICELaser 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.
DEVICEPseudo-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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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.
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| NRS on Day 8 | Day 8 after Taxanes treatment | Numerical rating scale in pain evaluation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation assessment | Day 1 and day 3 | Inflammation associated indices: C-Reactive protein |
| Functional Assessment of Cancer Therapy-General Scale on Day 8 | Day 8 | A Taxanes treatment questionnaire |
| 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 |
Countries
Taiwan
Outcome results
None listed