Chemotherapy-Induced Peripheral Neuropathy in Breast CancerNCT07092111
Efficacy of Auricular Acupuncture Therapy in the Prevention of CIPN in Breast Cancer
A study testing Auricular acupuncture treatment in people with Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Evaluate the Efficacy of Auricular Acupuncture Therapy via the Seirin Pyonex Needles in the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer
- What is being tested?
- Auricular acupuncture treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000
Wei Li, Ph.D, 25-68307102, real.lw@163.com
Wei Li, Ph.D
About this study
Official title: 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
Read the 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.
- Being tested
- Auricular acupuncture treatment, Sham acupuncture group
- Keywords
- chemotherapy-induced peripheral neuropathy, auricular acupuncture, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupuncture treatmentDevice
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 groupDevice
The treatment regimen is the same as that of the auricular acupuncture treatment group, but with a sham acupuncture (Seirin Pyonex Needles).
| Study group | Role | What they receive |
|---|---|---|
| Auricular acupuncture treatment group | Experimental | 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. Receives: Device: Auricular acupuncture treatment |
| Sham acupuncture group | Sham comparator | The treatment regimen is the same as that of the auricular acupuncture treatment group, but with a sham acupuncture (Seirin Pyonex Needles). Receives: Device: Sham acupuncture group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Jul 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Peripheral Neuropathy in Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092111
- Sponsor's protocol ID
- ACAA 01
- Status last verified
- Aug 2024
- First submitted
- 2 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Auricular Acupuncture Therapy Via the Seirin Pyonex Needles in the Prevention of Chemotherapy-Induced Peripheral Neuropathy(CIPN) in Breast Cancer
- ClinicalTrials.gov ID
- NCT07092111
- Acronym / sponsor ID
- ACAA 01
- Keywords
- chemotherapy-induced peripheral neuropathy, auricular acupuncture, breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular acupuncture treatment group | Experimental | Device: Auricular acupuncture treatmentOn 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. |
| Sham acupuncture group | Sham comparator | Device: Sham acupuncture groupThe treatment regimen is the same as that of the auricular acupuncture treatment group, but with a sham acupuncture (Seirin Pyonex Needles). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupuncture treatmentAuricular 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. | Device | Auricular acupuncture treatment group |
| Sham acupuncture groupThe 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 |
Primary outcome
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)
5 secondary outcomes
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)
CIPN neurotoxicity change
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
Time frame: From date of randomization until the date of he fourth application of taxane chemotherapy (up to 12 weeks)
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 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupuncture treatment in people with Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Li, Ph.D (025-68307102, real.lw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.