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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture group | Experimental | receive acupuncture treatment |
|
| Laser acupuncture group | Experimental | receive laser acupuncture treatment |
|
| Sham laser acupuncture group | Sham Comparator | receive sham-laser acupuncture treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Device | acupuncture |
| |
| laser acupuncture |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D060831 | Hand-Foot Syndrome |
| ID | Term |
|---|---|
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Device |
laser acupuncture |
|
| Sham-laser acupuncture | Device | Sham-laser acupuncture |
|
| 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 |
| D004342 |
| Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |