Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer
Conditions
Keywords
chemotherapy-induced peripheral neuropathy, auricular acupuncture, breast cancer
Brief summary
Evaluate the Efficacy of Auricular Acupuncture Therapy via the Seirin Pyonex Needles in the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer
Detailed description
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.
Interventions
DEVICEAuricular acupuncture treatment
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.
DEVICESham acupuncture group
The treatment regimen is the same as that of the auricular acupuncture treatment group, but with a sham acupuncture (Seirin Pyonex Needles).
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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); * Peripheral neuropathy or other neuropathic pain caused by diabetes mellitus or other factors related to HIV infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CIPN at the end of the 4th chemotherapy | From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks) | Incidence of CIPN at the end of the 4th application of taxane chemotherapy (according to NCI-CTCAE V5.0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CIPN at the end of the 3rd chemotherapy | From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks) | 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 | From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks) | 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 | From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks) | 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 | From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks) | 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. |
| The General Hospital Anxiety/Depression (HAD) | From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks) | 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. |
Countries
China
Contacts
Primary ContactWei Li, Ph.D
Outcome results
None listed