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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
acupuncture
laser acupuncture
Sham-laser acupuncture
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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from Baseline temperature at 3 weeks
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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from Baseline temperature at 6 weeks
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