The Efficacy of Acupuncture and Laser Acupuncture in Treating Chemotherapy or Target Therapy-induced Hand-foot Syndrome

Study Overview
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Brief Summary
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Chemotherapy or target therapy-induced hand-foot syndrome in cancer patients affects the quality of life. At present, there is no better treatment for this side effect of chemotherapy or target therapy. In severe cases, it is necessary to reduce the dose of chemotherapy or target therapy, which may affect the progress and effect of chemotherapy. In recent years, acupuncture has been widely used for many side effects of chemotherapy, such as numbness of hands and feet, gastrointestinal discomfort, and dizziness. There have been many studies have proved to be effective, but quite few studies explored the acupuncture treatment improves the hand-foot syndrome caused by chemotherapy or target therapy in cancer patients. Therefore, the investigators expect to evaluate the efficacy of acupuncture, and applying acupuncture or laser acupuncture to improve hand-foot syndrome caused by chemotherapy or target therapy in cancer patients in the future.

Detailed Description
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The investigators design a single-center, sham-controlled, assessor- and subject- blind, randomized clinical trial. 60 subjects will be equally and randomly divided into an acupuncture group, laser acupuncture, and sham-laser acupuncture groups in the 6-week trial. Each subject receives acupuncture, laser acupuncture, or sham-laser acupuncture three times a week for three consecutive weeks depending on their group, with a total of 9 times interventions. Outcome measures include Common adverse events evaluation standard version 5.0 (CTCAE) and Visual Analogue Scale (VAS), Dermatology Life Quality Index (DLQI) and assessment of cancer patients' quality of life questionnaire (EORTC QLQ-C30). ANSWatch and Thermal Image Camera are also used to assess those subjects. Those outcome measures will be conducted at baseline, the 3rd and the 6th week after the interventions.

Official Title
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The Efficacy of Acupuncture and Laser Acupuncture in Treating Chemotherapy or Target Therapy-induced Hand-foot Syndrome

Conditions
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Hand-Foot Syndrome

Intervention / Treatment
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* Device: acupuncture
* Device: laser acupuncture
* Device: Sham-laser acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer patients receiving chemotherapy or targeted therapy Age over 20 years old Western medicine diagnoses hand-foot syndrome Sign the consent form Exclusion Criteria: Pregnant or planning to become pregnant Serious arrhythmia (or cardiac pacemaker installed) Epilepsy Severe organ failure, such as heart and lung failure, liver and kidney failure Psychiatric history, unable to cooperate with acupuncture and assessors Those who received traditional Chinese medicine treatment for hand-foot skin reaction

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br>receive acupuncture treatment | Device: acupuncture<br>* acupuncture<br>|
| Experimental: Laser acupuncture group<br>receive laser acupuncture treatment | Device: laser acupuncture<br>* laser acupuncture<br>|
| Sham Comparator: Sham laser acupuncture group<br>receive sham-laser acupuncture treatment | Device: Sham-laser acupuncture<br>* Sham-laser acupuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0 | Evaluate skin symptoms assessed by Common Terminology Criteria for Adverse Events version 5. 0 (total three grade. Grade 1 is minimal skin changes, and grade 3 is severe skin changes) | Change from Baseline severity of hand-foot syndrome at 3 weeks | 
| The change of scores of Visual analogue scale (VAS) | pain evaluation assessed by Visual analogue scale, score from 0 (no pain) to 10 (unbearable pain) | Change from Baseline severity of pain at 3 weeks | 
| The change of Dermatology Life Quality Index (questionnaire) | evaluate quality of life assessed by Dermatology Life Quality Index | Change from Baseline quality of life at 3 weeks | 
| The change of EORTC QLQ-C30 (questionnaire) | evaluate quality of life assessed by EORTC QLQ-C30 | Change from Baseline quality of life at 3 weeks | 
| The change of LF/HF before and after treatment | testing LF/HF assessed by ANSWatch wrist monitor | Change from Baseline LF/HF at 3 weeks | 
| The change of temperature of limbs before and after treatment | testing temperature assessed by Thermal Imaging Analysis | Change from Baseline temperature at 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Common Terminology Criteria for Adverse Events (CTCAE) version 5. 0 | Evaluate skin symptoms assessed by Common Terminology Criteria for Adverse Events version 5. 0 (total three grade. Grade 1 is minimal skin changes, and grade 3 is severe skin changes) | Change from Baseline severity of hand-foot syndrome at 6 weeks | 
| The change of scores of Visual analogue scale (VAS) | pain evaluation assessed by Visual analogue scale, score from 0 (no pain) to 10 (unbearable pain) | Change from Baseline severity of pain at 6 weeks | 
| The change of Dermatology Life Quality Index (questionnaire) | evaluate quality of life assessed by Dermatology Life Quality Index | Change from Baseline quality of life at 6 weeks | 
| The change of EORTC QLQ-C30 (questionnaire) | evaluate quality of life assessed by EORTC QLQ-C30 | Change from Baseline quality of life at 6 weeks | 
| The change of LF/HF before and after treatment | testing LF/HF assessed by ANSWatch wrist monitorng LF/HF | Change from Baseline LF/HF at 6 weeks | 
| The change of temperature of limbs before and after treatment | testing temperature assessed by Thermal Imaging Analysis | Change from Baseline temperature at 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, laser acupuncture, chemotherapy, target therapy, hand-foot syndrome