Breast CancerNCT07377279
Acupuncture and Compression for the Prevention of CIPN in Breast Cancer Patients
A study testing Compression, Acupuncture and Compression combined with acupuncture in people with Breast Cancer and Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
As a core component of comprehensive breast cancer treatment, chemotherapy frequently induces chemotherapy-induced peripheral neuropathy (CIPN), particularly with taxane-based agents. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer, Chemotherapy-induced Peripheral Neuropathy (CIPN)
- What is being tested?
- Compression, Acupuncture and Compression combined with acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old and have signed an informed consent form;
- Patients with histologically confirmed non-recurrent early or intermediate-stage breast cancer;
- Patients scheduled to receive cyclical adjuvant or neoadjuvant chemotherapy based on taxane drugs (4-cycle or single-cycle regimen);
- No prior exposure to breast cancer-related chemotherapy, immunotherapy, or endocrine therapy;
- Cardiac echocardiography showing cardiac ejection fraction within normal range;
- Eastern Cooperative Oncology Group (ECOG) physical status ≤1;
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- No psychiatric or cognitive impairments, capable of understanding and completing assessment scales;
- No CIPN at baseline (NCI-CTCAE 5.0 and TNSc grading ≤0);
- Good organ function meeting the following criteria: Hb ≥90g/L, WBC ≥3.5×10⁹/L, platelets ≥100×10⁹/L, neutrophils ≥1.5×10⁹/L, AST ≤3× upper limit of normal, ALT ≤3× upper limit of normal, bilirubin ≤1.5× upper limit of normal, serum creatinine ≤1.5× upper limit of normal;
- Fertile women must agree to use effective contraception for 7 days before first dosing through 24 weeks post-treatment. Fertile women must have a negative serum pregnancy test within 7 days before first dosing.
Who cannot join
- Patients with active infections, skin lesions on hands/feet, or contraindications to chemotherapy, acupuncture, or compression therapy;
- Patients with prior exposure to neurotoxic agents (e.g., taxanes, oxaliplatin, platinum-based drugs, vincristine) or platinum-containing chemotherapy regimens;
- Patients who received acupuncture for other conditions within the past month;
- Patients with conditions predisposing to peripheral neuropathy symptoms (e.g., alcoholism, uremia, diabetes, autoimmune disorders, rheumatoid arthritis, cervical spondylosis, severe mental illness, severe trauma);
- Patients with Raynaud's syndrome, cold intolerance, peripheral arterial ischemia, or hand-foot syndrome;
- Patients receiving medications that may mask CIPN symptoms (e.g., SSNRI, SSRI, tricyclic antidepressants, B-complex vitamins);
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- Patients with lymphedema in acupuncture stimulation areas;
- Patients with phobia of electroacupuncture or stainless steel needle allergy;
- Patients with severe non-malignant conditions that may compromise treatment adherence or pose risks;
- Patients undergoing concurrent anti-tumor therapy or clinical trials;
- Patients with dementia, cognitive impairment, or psychiatric conditions affecting informed consent comprehension;
- Patients with known allergy history or contraindications to trial procedures;
- Patients with uncontrolled cardiac symptoms or conditions, including: (1) NYHA class 2 or higher heart failure; (2) unstable angina; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment;
- Cardiac pacemaker implantation;
- Known hereditary or acquired bleeding/thrombosis predispositions (e.g., hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Breast Tumor Center, Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510000
Jieqiong Liu, 086-13922272706, liujieqiong01@163.com
About this study
Official title: Acupuncture and Compression for the Prevention of Peripheral Neuropathy Induced by Taxane-based Chemotherapy in Breast Cancer Patients: A Randomized Controlled Trial
As a core component of comprehensive breast cancer treatment, chemotherapy frequently induces chemotherapy-induced peripheral neuropathy (CIPN), particularly with taxane-based agents. The incidence of CIPN reaches 68.1% within the first month of chemotherapy, and over 30% of patients experience persistent symptoms for more than 6 months. The resulting sensorimotor dysfunction significantly impairs patients' quality of life, necessitates dose reduction or treatment discontinuation, and ultimately affects survival outcomes. Currently, no prophylactic pharmacological or non-pharmacological interventions have received Grade I recommendations in domestic or international guidelines and expert consensuses. The compression therapy demonstrated definite preventive value in the POLAR trial. Its low cost and high tolerability confer substantial clinical applicability, earning it a Grade III recommendation in ESMO guidelines. Meanwhile, single-arm trials of acupuncture have reported a 51.2% symptom relief rate and a trend toward reduced high-grade CIPN. As non-pharmacological interventions, acupuncture and compression therapy hold complementary potential in preventing taxane-induced CIPN: compression therapy locally blocks drug exposure, while acupuncture systemically regulates neural function.However, three core challenges persist in the current research field: insufficient evidence quality for single-intervention strategies, lack of systematic evaluation of combined interventions, and the absence of risk-stratified prevention models. To address these gaps, this study aims to conduct a prospective randomized controlled trial to concurrently evaluate the preventive efficacy of compression therapy, acupuncture, and their combination for taxane-induced CIPN. The goal is to provide high-level evidence-based medicine to support the development of individualized prevention strategies.
- Being tested
- Compression, Acupuncture, Sham acupuncture, Compression combined with acupuncture
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CompressionOther
Two layers of latex gloves are worn on both hands, and Class II compression stockings are worn on both feet. The devices are donned 30 minutes before chemotherapy initiation and removed 30 minutes after chemotherapy completion.
AcupunctureOther
Acupuncture is administered consecutively for 3-5 days starting from Day 1 post each chemotherapy cycle, with electrical stimulation applied for 20-30 minutes per session. The selected acupoints included: PC6, LI4, SI3, ST36, SP6, LR3, SP4, EX-LE10.
Sham acupunctureOther
A shallow needling at non-acupoint sites (sham acupuncture) is adopted. The stimulation locations are non-acupoint areas 1-2 cun away from the standard acupoint positions. For the sham acupuncture group, needles are inserted superficially to a depth of 2-3 mm without manipulation, with the endpoint of no deqi sensation. Operational elements including needle type, patient posture, disinfection method, needle insertion technique, needle retention time, and needle withdrawal technique are identical between the sham acupuncture group and the active acupuncture group.
Compression combined with acupunctureOther
Two layers of latex gloves are worn on both hands, and Class II compression stockings are worn on both feet. The devices are donned 30 minutes before chemotherapy initiation and removed 30 minutes after chemotherapy completion. Acupuncture is administered consecutively for 3-5 days starting from Day 1 post each chemotherapy cycle, with electrical stimulation applied for 20-30 minutes per session. The selected acupoints included: PC6, LI4, SI3, ST36, SP6, LR3, SP4, EX-LE10.
| Study group | Role | What they receive |
|---|---|---|
| Compression | Experimental | Latex gloves and compression stockings are worn during chemotherapy. Receives: Other: Compression |
| Acupuncture | Experimental | Electroacupuncture treatment is administered after each chemotherapy cycle and continuing consecutively for 3-5 days. Receives: Other: Acupuncture |
| Compression combined with acupuncture | Experimental | Compression therapy will be administered during chemotherapy, combined with consecutive electroacupuncture for 3-5 days after each chemotherapy cycle. Receives: Other: Compression combined with acupuncture |
| Sham acupuncture | Placebo comparator | A shallow needling at non-acupoint sites (sham acupuncture) is inserted superficially to a depth of 2-3 mm without manipulation. Receives: Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade ≥2 CIPN at 12 weeks after the initiation of chemotherapy
The incidence of CIPN ≥ grade 2 is assessed according to the NCI-CTCAE v5.0 criteria.
Measured: 12 weeks after the initiation of chemotherapy
Secondary outcomes (7)
Incidence of CIPN
The incidence of CIPN at 6 and 12 weeks after chemotherapy initiation, and at 12 and 24 weeks after chemotherapy completion
Measured: 6 and 12 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion
Incidence of grade ≥2 CIPN at 6 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion
The incidence of CIPN ≥2 grade at 6 weeks after chemotherapy initiation, 12 weeks after chemotherapy completion, and 24 weeks after chemotherapy completion.
Measured: 6 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion
Assessment of quality of life via the EORTC QLQ-C30 questionnaire.
Patient reported outcomes via the European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC QLQ-C30). It contains 30 items and measures 5 functional scales (physical, role, emotional, cognitive, and social), a global health and quality of life scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact). The global health and quality of life scale uses a 7-point scale scoring with anchors (1=very poor and 7=excellent); the other items are scored on a 4 point scale (1=not at all, 2=a little, 3= quite a bit, 4=very much).
Measured: Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy.
Assessment of sensation and motor function via the EORTC QLQ-CIPN20 questionnaire.
Patient reported outcomes via the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (EORTC QLQ-CIPN20). It contains 20 items divided into 3 subscales assessing sensory, motor and autonomic symptoms. Each item is scored on a Likert scale ranging from 1 'not at all' to 4 'very much'. Scores are transformed to a 0-100 scale, with higher scores representing more complaints.
Measured: Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy.
Nail toxicity
Nail toxicity is assessed according to the National Cancer Institute Toxicity Criteria 4.0 (NCI 4.0).
Measured: Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy.
Objective neurological function
Use quantitative sensory testing to assess vibration perception (128Hz tuning fork, dorsal threshold>8 seconds) and tactile sensation (10g monofilament, no response at ≥2 of 4 hand/foot points).
Measured: Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy.
Adverse event incidence rate
Adverse events at all levels associated with treatment and interventions
Measured: 8 months (during taxane therapy and follow up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jieqiong Liu, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377279
- Sponsor's protocol ID
- SYSKY-2025-870-02
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Compression for the Prevention of Peripheral Neuropathy Induced by Taxane-based Chemotherapy in Breast Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07377279
- Acronym / sponsor ID
- SYSKY-2025-870-02
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 29 Jan 2026 (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.
As a core component of comprehensive breast cancer treatment, chemotherapy frequently induces chemotherapy-induced peripheral neuropathy (CIPN), particularly with taxane-based agents. The incidence of CIPN reaches 68.1% within the first month of chemotherapy, and over 30% of patients experience persistent symptoms for more than 6 months. The resulting sensorimotor dysfunction significantly impairs patients' quality of life, necessitates dose reduction or treatment discontinuation, and ultimately affects survival outcomes. Currently, no prophylactic pharmacological or non-pharmacological interventions have received Grade I recommendations in domestic or international guidelines and expert consensuses. The compression therapy demonstrated definite preventive value in the POLAR trial. Its low cost and high tolerability confer substantial clinical applicability, earning it a Grade III recommendation in ESMO guidelines. Meanwhile, single-arm trials of acupuncture have reported a 51.2% symptom relief rate and a trend toward reduced high-grade CIPN. As non-pharmacological interventions, acupuncture and compression therapy hold complementary potential in preventing taxane-induced CIPN: compression therapy locally blocks drug exposure, while acupuncture systemically regulates neural function.However, three core challenges persist in the current research field: insufficient evidence quality for single-intervention strategies, lack of systematic evaluation of combined interventions, and the absence of risk-stratified prevention models. To address these gaps, this study aims to conduct a prospective randomized controlled trial to concurrently evaluate the preventive efficacy of compression therapy, acupuncture, and their combination for taxane-induced CIPN. The goal is to provide high-level evidence-based medicine to support the development of individualized prevention strategies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Compression | Experimental | Other: CompressionLatex gloves and compression stockings are worn during chemotherapy. |
| Acupuncture | Experimental | Other: AcupunctureElectroacupuncture treatment is administered after each chemotherapy cycle and continuing consecutively for 3-5 days. |
| Compression combined with acupuncture | Experimental | Other: Compression combined with acupunctureCompression therapy will be administered during chemotherapy, combined with consecutive electroacupuncture for 3-5 days after each chemotherapy cycle. |
| Sham acupuncture | Placebo comparator | Other: Sham acupunctureA shallow needling at non-acupoint sites (sham acupuncture) is inserted superficially to a depth of 2-3 mm without manipulation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-70 years old and have signed an informed consent form;
- Patients with histologically confirmed non-recurrent early or intermediate-stage breast cancer;
- Patients scheduled to receive cyclical adjuvant or neoadjuvant chemotherapy based on taxane drugs (4-cycle or single-cycle regimen);
- No prior exposure to breast cancer-related chemotherapy, immunotherapy, or endocrine therapy;
- Cardiac echocardiography showing cardiac ejection fraction within normal range;
Key exclusion criteria (15 listed)
- Patients with active infections, skin lesions on hands/feet, or contraindications to chemotherapy, acupuncture, or compression therapy;
- Patients with prior exposure to neurotoxic agents (e.g., taxanes, oxaliplatin, platinum-based drugs, vincristine) or platinum-containing chemotherapy regimens;
- Patients who received acupuncture for other conditions within the past month;
- Patients with conditions predisposing to peripheral neuropathy symptoms (e.g., alcoholism, uremia, diabetes, autoimmune disorders, rheumatoid arthritis, cervical spondylosis, severe mental illness, severe trauma);
- Patients with Raynaud's syndrome, cold intolerance, peripheral arterial ischemia, or hand-foot syndrome;
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 |
|---|---|---|
| CompressionTwo layers of latex gloves are worn on both hands, and Class II compression stockings are worn on both feet. The devices are donned 30 minutes before chemotherapy initiation and removed 30 minutes after chemotherapy completion. | Other | Compression |
| AcupunctureAcupuncture is administered consecutively for 3-5 days starting from Day 1 post each chemotherapy cycle, with electrical stimulation applied for 20-30 minutes per session. The selected acupoints included: PC6, LI4, SI3, ST36, SP6, LR3, SP4, EX-LE10. | Other | Acupuncture |
| Sham acupunctureA shallow needling at non-acupoint sites (sham acupuncture) is adopted. The stimulation locations are non-acupoint areas 1-2 cun away from the standard acupoint positions. For the sham acupuncture group, needles are inserted superficially to a depth of 2-3 mm without manipulation, with the endpoint of no deqi sensation. Operational elements including needle type, patient posture, disinfection method, needle insertion technique, needle retention time, and needle withdrawal technique are identical between the sham acupuncture group and the active acupuncture group. | Other | Sham acupuncture |
| Compression combined with acupunctureTwo layers of latex gloves are worn on both hands, and Class II compression stockings are worn on both feet. The devices are donned 30 minutes before chemotherapy initiation and removed 30 minutes after chemotherapy completion. Acupuncture is administered consecutively for 3-5 days starting from Day 1 post each chemotherapy cycle, with electrical stimulation applied for 20-30 minutes per session. The selected acupoints included: PC6, LI4, SI3, ST36, SP6, LR3, SP4, EX-LE10. | Other | Compression combined with acupuncture |
Primary outcome
Incidence of grade ≥2 CIPN at 12 weeks after the initiation of chemotherapy
Time frame: 12 weeks after the initiation of chemotherapy
The incidence of CIPN ≥ grade 2 is assessed according to the NCI-CTCAE v5.0 criteria.
7 secondary outcomes
Incidence of CIPN
Time frame: 6 and 12 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion
Incidence of grade ≥2 CIPN at 6 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion
Time frame: 6 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion
Assessment of quality of life via the EORTC QLQ-C30 questionnaire.
Time frame: Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy.
Assessment of sensation and motor function via the EORTC QLQ-CIPN20 questionnaire.
Time frame: Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy.
Nail toxicity
Time frame: Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy.
Objective neurological function
Time frame: Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy.
Adverse event incidence rate
Time frame: 8 months (during taxane therapy and follow up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression, Acupuncture and Compression combined with acupuncture in people with Breast Cancer and Chemotherapy-induced Peripheral Neuropathy (CIPN), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 2 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jieqiong Liu (86-13922272706, liujieqiong01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade ≥2 CIPN at 12 weeks after the initiation of chemotherapy (time frame: 12 weeks after the initiation of chemotherapy). 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 2 Feb 2026.