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

NCT ID: NCT07092111

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Auricular acupuncture treatment

Intervention Type 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

The treatment regimen is the same as that of the auricular acupuncture treatment group, but with a sham acupuncture (Seirin Pyonex Needles).

Group Type SHAM_COMPARATOR

Sham acupuncture group

Intervention Type DEVICE

The treatment regimen is the same as that of the auricular acupuncture treatment group, but with a sham acupuncture (Seirin Pyonex Needles).

Interventions

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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.

Intervention Type 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).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Li, Ph.D

Role: CONTACT

025-68307102

Facility Contacts

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Wei Li, Ph.D

Role: primary

25-68307102

Other Identifiers

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ACAA 01

Identifier Type: -

Identifier Source: org_study_id

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