Auricular acupuncture to prevent chemotherapy-related nerve damage in breast cancer

Efficacy of Auricular Acupuncture Therapy Via the Seirin Pyonex Needles in the Prevention of Chemotherapy-Induced Peripheral Neuropathy(CIPN) in Breast Cancer

Researchers will test whether regular ear (auricular) acupuncture with Seirin Pyonex needles can prevent or reduce chemotherapy-induced peripheral neuropathy in women receiving taxane chemotherapy for stage I–III breast cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07092111 on ClinicalTrials.gov

What this trial studies

This is a randomized, controlled Phase II trial comparing auricular acupuncture using Seirin Pyonex needles to a sham acupuncture procedure in women with stage I–III breast cancer. Participants receive the assigned ear acupuncture intervention while undergoing four planned cycles of taxane chemotherapy. The study will monitor the development and severity of chemotherapy-induced peripheral neuropathy during and after treatment using standard clinical grading and patient-reported measures. Patients with preexisting neuropathy, recent acupuncture, or contraindications such as low platelets or local infection are excluded.

Who should consider this trial

Good fit: Women aged 18–75 with stage I–III breast cancer who are scheduled to receive four cycles of taxane chemotherapy, have not had recent neurostabilizing drugs, and can give informed consent are ideal candidates.

Not a fit: Patients who already have grade ≥1 CIPN, diabetic or other non-chemotherapy neuropathy, recent acupuncture, platelet counts <50,000/µL, or local infection at the ear site are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the approach could lower the chance or severity of nerve damage from taxane chemotherapy and improve patients' quality of life.

How similar studies have performed: Some small trials of acupuncture for chemotherapy neuropathy have shown mixed or modest benefits, but prevention with auricular Pyonex needles in taxane-treated breast cancer is largely novel and not well established.

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.

Where this trial is running

Nanjing, Jiangsu

• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Wei Li, Ph.D

Conditions Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer; chemotherapy-induced peripheral neuropathy; auricular acupuncture; breast cancer