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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Auricular acupuncture treatment groupExperimental treatment 1 intervention
Group B: Sham acupuncture groupSham comparator 1 intervention

Trial outcomes

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)

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

Secondary outcomes

1

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.

Time frame
From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)
2

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.

Time frame
From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)
3

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.

Time frame
From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)
4

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.

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

Other outcomes

Sponsors and contacts

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