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

NCT04872556 | Terminated DMC

• 1 other identifier: 202001710A3
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Cancer; Joint Pain

Keywords

Laser acupuncture; Taxanes; Chemotherapy; Cancer; Myalgia; Arthralgia

Outcome Measures

Primary Outcomes (3)

• NRS on Day 1

  Numerical rating scale in pain evaluation

  Day 1 after Taxanes treatment

• NRS on Day 3

  Numerical rating scale in pain evaluation

  Day 3 after Taxanes treatment

• NRS on Day 8

  Numerical rating scale in pain evaluation

  Day 8 after Taxanes treatment

Secondary Outcomes (6)

• Inflammation assessment

  Day 1 and day 3

• Inflammation assessment

  Day 1 and day 3

• Inflammation assessment

  Day 1 and day 3

• Functional Assessment of Cancer Therapy-General Scale on Day 1

  Day 1

• Functional Assessment of Cancer Therapy-General Scale on Day 3

  Day 3

Study Arms (2)

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.

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.

Device: Pseudo-laser acupuncture

Interventions

Laser acupuncture device 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.

Laser acupuncture group

Pseudo-laser acupuncture DEVICE

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.

Pseudo-laser acupuncture group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

ChangGung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Cancer Pain; Arthralgia; Neoplasms; Myalgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 4, 2021
• Study Start: May 13, 2021
• Primary Completion: December 31, 2021
• Study Completion: February 24, 2022
• Last Updated: February 8, 2024

Record last verified: 2021-03

Locations

TW (1)