Efficacy of Auricular Acupuncture Therapy in the Prevention of CIPN in Breast Cancer

NCT07092111 | Recruiting

• 1 other identifier: ACAA 01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer

Keywords

chemotherapy-induced peripheral neuropathy; auricular acupuncture; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• 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)

• CIPN neurotoxicity change

  From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)

• The degree of sensory impairment

  From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)

• The pain intensity score

  From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)

• The General Hospital Anxiety/Depression (HAD)

  From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)

Study Arms (2)

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.

Device: Auricular acupuncture treatment

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).

Device: Sham acupuncture group

Interventions

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.

Auricular acupuncture treatment group

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).

Sham acupuncture group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Patient is an adult female ≥ 18 years old at the time of informed consent.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• years old≤ age≤ 75 years old, female;
• Subjects voluntarily participate in this trial and sign the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Wei Li, Ph.D

CONTACT

025-68307102; real.lw@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 29, 2025
• Study Start: July 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 29, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)