Efficacy of Auricular Acupuncture Therapy in the Prevention of CIPN in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Auricular acupuncture treatment, Sham acupuncture group.
- Who it may be relevant to
- Registry conditions: Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Auricular Acupuncture Therapy Via the Seirin Pyonex Needles in the Prevention of Chemotherapy-Induced Peripheral Neuropathy(CIPN) in Breast Cancer
Overview
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
- Device Auricular 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 ventrolat - Device Sham acupuncture group
The treatment regimen is the same as that of the auricular acupuncture treatment group, but with a sham acupuncture (Seirin Pyonex Needles).
Primary outcome measures
- Incidence of CIPN at the end of the 4th chemotherapy [Time frame: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)]
Secondary outcome measures (5)
- Incidence of CIPN at the end of the 3rd chemotherapy [Time frame: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)]
- CIPN neurotoxicity change [Time frame: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)]
- The degree of sensory impairment [Time frame: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)]
- The pain intensity score [Time frame: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)]
- The General Hospital Anxiety/Depression (HAD) [Time frame: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Jiangsu Provincial People's Hospital — Nanjing
Identifiers
NCT: NCT07092111 · ACAA 01