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NCT Number: NCT07092111

Efficacy of Auricular Acupuncture Therapy in the Prevention of 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

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Key information

Conditions

Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210000, China

Location status: Recruiting

Location contact

Wei Li, Ph.D

CONTACT

[email protected]

25-68307102

Wei Li, Ph.D

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

Primary outcomes

  1. 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)

    Incidence of CIPN at the end of the 4th application of taxane chemotherapy (according to NCI-CTCAE V5.0)

Secondary outcomes

  1. 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)

    Incidence of CIPN before the first treatment, at the end of the first three taxane chemotherapy treatments, and at 2 months of follow-up.

  2. CIPN neurotoxicity change

    Time frame: 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.

  3. 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 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.

  4. 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 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.

  5. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Li, Ph.D

CONTACT

[email protected]

025-68307102

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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