About this trial
Evaluate the Efficacy of Auricular Acupuncture Therapy via the Seirin Pyonex Needles in the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with breast cancer diagnosed with stage I-III;
Planned to receive 4 cycles of taxane chemotherapy and have not taken neurostable drugs within three months;
18 years old≤ age≤ 75 years old, female;
Subjects voluntarily participate in this trial and sign the informed consent form.
Disqualifiers
Patients who have had acupuncture treatment in the past;
After examination by a doctor, there is a local infection at or near the acupuncture site, which is not suitable for acupuncture.
Platelets< 50,000/μL;
Patients with CIPN≥1 grade 1 (NCI-CTCAE);
Trial design
Parallel
Treatments tested in this trial
Auricular acupuncture treatment
DeviceAuricular 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.
Sham acupuncture group
DeviceThe treatment regimen is the same as that of the auricular acupuncture treatment group, but with a sham acupuncture (Seirin Pyonex Needles).
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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.
CIPN neurotoxicity change
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.
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.
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.
Sponsors and contacts
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