Pain CancerNCT04872556
Evaluation of the Effect of Laser Acupuncture on Taxane Acute Pain Syndrome Patients
A study testing Laser acupuncture device and Pseudo-laser acupuncture in people with Pain Cancer and Joint Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pain Cancer, Joint Pain
- What is being tested?
- Laser acupuncture device and Pseudo-laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 May 2021to 24 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Laser Acupuncture on Myalgia and Arthralgia During Docetaxel or Paclitaxel Treatment in Cancer Patients
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.
Read the 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.
- Conditions
- Pain Cancer, Joint Pain
- Being tested
- Laser acupuncture device, Pseudo-laser acupuncture
- Keywords
- Laser acupuncture, Taxanes, Chemotherapy, Cancer, Myalgia, Arthralgia
- Medical subject headings
- Cancer Pain, Arthralgia, Neoplasms, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupuncture deviceDevice
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.
Pseudo-laser acupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture group | Experimental | 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. Receives: Device: Laser acupuncture device |
| Pseudo-laser acupuncture group | Sham comparator | 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. Receives: Device: Pseudo-laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS on Day 1
Numerical rating scale in pain evaluation
Measured: Day 1 after Taxanes treatment
NRS on Day 3
Numerical rating scale in pain evaluation
Measured: Day 3 after Taxanes treatment
NRS on Day 8
Numerical rating scale in pain evaluation
Measured: Day 8 after Taxanes treatment
Secondary outcomes (6)
Inflammation assessment
Inflammation associated indices: C-Reactive protein
Measured: Day 1 and day 3
Inflammation assessment
Inflammation associated indices: erythrocyte sedimentation rate
Measured: Day 1 and day 3
Inflammation assessment
Inflammation associated indices: Interleukin-6
Measured: Day 1 and day 3
Functional Assessment of Cancer Therapy-General Scale on Day 1
A Taxanes treatment questionnaire
Measured: Day 1
Functional Assessment of Cancer Therapy-General Scale on Day 3
A Taxanes treatment questionnaire
Measured: Day 3
Functional Assessment of Cancer Therapy-General Scale on Day 8
A Taxanes treatment questionnaire
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start13 May 2021
- Primary completion31 Dec 2021
- Study completion24 Feb 2022
Why it stopped: end of the supporting fund
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872556
- Sponsor's protocol ID
- 202001710A3
- Status last verified
- Mar 2021
- First submitted
- 21 Apr 2021
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Laser Acupuncture on Myalgia and Arthralgia During Docetaxel or Paclitaxel Treatment in Cancer Patients
- ClinicalTrials.gov ID
- NCT04872556
- Acronym / sponsor ID
- 202001710A3
- Conditions
- Pain Cancer, Joint Pain
- Keywords
- Laser acupuncture, Taxanes, Chemotherapy, Cancer, Myalgia, Arthralgia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end of the supporting fund
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 13 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture group | Experimental | Device: Laser acupuncture deviceThe 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 | Sham comparator | Device: Pseudo-laser acupunctureThe 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser acupuncture deviceThe 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 | Laser acupuncture group |
| Pseudo-laser acupunctureThe 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. | Device | Pseudo-laser acupuncture group |
Primary outcome
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
6 secondary outcomes
Inflammation assessment
Time frame: Day 1 and day 3
Inflammation assessment
Time frame: Day 1 and day 3
Inflammation assessment
Time frame: Day 1 and day 3
Functional Assessment of Cancer Therapy-General Scale on Day 1
Time frame: Day 1
Functional Assessment of Cancer Therapy-General Scale on Day 3
Time frame: Day 3
Functional Assessment of Cancer Therapy-General Scale on Day 8
Time frame: Day 8
Results and safety
The study was stopped early (reason given: end of the supporting fund). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture device and Pseudo-laser acupuncture in people with Pain Cancer and Joint Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: end of the supporting fund). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS on Day 1 (time frame: Day 1 after Taxanes treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.