Efficacy of Auricular Acupuncture Therapy in the Prevention of CIPN 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

Evaluate the Efficacy of Auricular Acupuncture Therapy via the Seirin Pyonex Needles in the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer
• Intervention / Treatment: Device: Auricular acupuncture treatment; Device: Sham acupuncture group

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Li, Ph.D; Phone Number: 025-68307102; Email: real.lw@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Jiangsu Provincial People's Hospital
      • Principal Investigator: Wei Li, Ph.D
      • Contact: Wei Li, Ph.D; Phone Number: 25-68307102; Email: real.lw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auricular acupuncture treatment group; 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; 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.
Sham Comparator: 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)
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.	From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)
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.	From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)
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.	From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)
The General Hospital Anxiety/Depression (HAD)	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.	From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 2, 2025
• First Submitted That Met QC Criteria: July 21, 2025
• First Posted (Actual): July 29, 2025

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; chemotherapy-induced peripheral neuropathy; auricular acupuncture
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Skin Diseases; Breast Diseases; Breast Neoplasms; Peripheral Nervous System Diseases
• Other Study ID Numbers: ACAA 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No