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Evaluate the Efficacy of Auricular Acupuncture Therapy via the Seirin Pyonex Needles in the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer
This is a Phase II Randomised Controlled Clinical Trial to evaluate the efficacy of auricular acupuncture therapy via the Seirin Pyonex Needles in the prevention of chemotherapy-induced peripheral neuropathy in breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auricular acupuncture treatment group | Experimental | On the basis of conventional nursing, patients are treated with bilateral auricular acupuncture points (Seirin Pyonex Needles φ 0.2 mm × 1.2 mm) before chemotherapy. Specific operation: 1 treatment before each chemotherapy treatment, and 2 treatments a week in the 2nd and 3rd weeks of the chemotherapy interval. The patient was instructed to press the acupuncture point for 3 times/d, the pressure time was 5min, and the local swelling pain was tolerated by the patient. The doctor took the needle out for the patient after leaving it for 3 days. Treatment was continued for 4 cycles of chemotherapy, followed up for 2 months after treatment completion, and routine care was carried out during treatment. |
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| Sham acupuncture group | Sham Comparator | The treatment regimen is the same as that of the auricular acupuncture treatment group, but with a sham acupuncture (Seirin Pyonex Needles). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular acupuncture treatment | Device | Auricular acupuncture is an innovative intradermal acupuncture, which can directly use the meridian system of the ear skin to directly transmit the received stimulation to the lesion. Its stimulation time is long, and the amount of stimulation is strong. Studies have shown that needle pricking continuously delivers an adequate dose of acupuncture stimulation by continuously stimulating Aβ, Aδ, and/or C afferent fibers from the skin and transmitting them to the brain nucleus through the ventrolateral cord of the spinal cord. It is also believed that by stimulating the cranial nerves, especially the auricular branch of the vagus nerve, the effect of sensory afferent peripheral stimulation can be enhanced, and the analgesic effect of the auricular acupoints can be achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CIPN at the end of the 4th chemotherapy | Incidence of CIPN at the end of the 4th application of taxane chemotherapy (according to NCI-CTCAE V5.0) | From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CIPN at the end of the 3rd chemotherapy | Incidence of CIPN before the first treatment, at the end of the first three taxane chemotherapy treatments, and at 2 months of follow-up. | From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks) |
| CIPN neurotoxicity change |
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Inclusion Criteria:
Exclusion Criteria:
Patient is an adult female ≥ 18 years old at the time of informed consent.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Li, Ph.D | Contact | 025-68307102 | real.lw@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial People's Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Sham acupuncture group | Device | The treatment regimen is the same as that of the auricular acupuncture treatment group, but with a sham acupuncture (Seirin Pyonex Needles). |
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The FACT/GOG-Ntx scale was used to evaluate the change in CIPN neurotoxicity symptom scores before the first treatment, at the end of the second taxane chemotherapy, at the end of the fourth taxane chemotherapy, and at 2 months of follow-up. |
| From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks) |
| The degree of sensory impairment | The degree of sensory impairment was assessed by Semmes-Weinstein monofilament tactile test before the first treatment, at the end of the fourth taxane chemotherapy, and at 2 months of follow-up. | From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks) |
| The pain intensity score | The NRS scale assessed the pain intensity score before the first treatment, at the end of the second taxane chemotherapy, at the end of the fourth taxane chemotherapy, and at 2 months of follow-up. | From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks) |
| The General Hospital Anxiety/Depression (HAD) | The General Hospital Anxiety/Depression (HAD) Mood Measurement Form was used to evaluate the physical fitness score of patients before the first treatment and at the end of the fourth taxane chemotherapy. | From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks) |
| D017437 |
| Skin and Connective Tissue Diseases |