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

Nanjing Medical University

Status: Enrolling

Conditions: Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer

Treatments: Device: Auricular acupuncture treatment; Device: Sham acupuncture group

Study type: Interventional

Funder types: Other

Identifiers

NCT07092111

ACAA 01

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Auricular acupuncture treatment group

Experimental group

Description:

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.

Treatment:

Device: Auricular acupuncture treatment

Sham acupuncture group

Sham Comparator group

Description:

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

Treatment:

Device: Sham acupuncture group