Acupuncture and compression to prevent chemotherapy-induced nerve damage in breast cancer

Acupuncture and Compression for the Prevention of Peripheral Neuropathy Induced by Taxane-based Chemotherapy in Breast Cancer Patients: A Randomized Controlled Trial

This trial will test whether wearing compression garments and/or receiving acupuncture during taxane chemotherapy can prevent chemotherapy-induced peripheral neuropathy in adults with early-stage breast cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 384 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07377279 on ClinicalTrials.gov

What this trial studies

Adults with non-recurrent early or intermediate-stage breast cancer scheduled for taxane-based adjuvant or neoadjuvant chemotherapy and without baseline neuropathy will be enrolled at Sun Yat-sen Memorial Hospital. Participants will be assigned to receive compression therapy, acupuncture, sham acupuncture, or a combination of compression plus acupuncture alongside standard chemotherapy. The study will monitor the incidence and severity of CIPN using clinical grading and neuropathy scales throughout treatment and follow-up. The design builds on POLAR trial evidence for compression and prior single-arm acupuncture reports to test individual and combined preventive effects.

Who should consider this trial

Good fit: Ideal candidates are 18–70 years old with histologically confirmed early or intermediate non-recurrent breast cancer who have not received prior systemic breast cancer therapy and have no baseline neuropathy.

Not a fit: Patients with recurrent or metastatic disease, pre-existing CIPN, prior breast cancer chemotherapy/immunotherapy/endocrine therapy, or significant organ dysfunction are not eligible and would not be expected to benefit from this protocol.

Why it matters

Potential benefit: If successful, these low-cost, well-tolerated interventions could reduce the risk of developing CIPN, help patients complete planned chemotherapy, and preserve quality of life.

How similar studies have performed: Compression demonstrated preventive benefit in the POLAR trial and acupuncture has shown promising results in single-arm studies, but combined approaches lack definitive randomized confirmation.

Eligibility criteria

Inclusion Criteria:

1. Age 18-70 years old and have signed an informed consent form;
2. Patients with histologically confirmed non-recurrent early or intermediate-stage breast cancer;
3. Patients scheduled to receive cyclical adjuvant or neoadjuvant chemotherapy based on taxane drugs (4-cycle or single-cycle regimen);
4. No prior exposure to breast cancer-related chemotherapy, immunotherapy, or endocrine therapy;
5. Cardiac echocardiography showing cardiac ejection fraction within normal range;
6. Eastern Cooperative Oncology Group (ECOG) physical status ≤1;
7. No psychiatric or cognitive impairments, capable of understanding and completing assessment scales;
8. No CIPN at baseline (NCI-CTCAE 5.0 and TNSc grading ≤0);
9. 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;
10. 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.

Exclusion Criteria:

1. Patients with active infections, skin lesions on hands/feet, or contraindications to chemotherapy, acupuncture, or compression therapy;
2. Patients with prior exposure to neurotoxic agents (e.g., taxanes, oxaliplatin, platinum-based drugs, vincristine) or platinum-containing chemotherapy regimens;
3. Patients who received acupuncture for other conditions within the past month;
4. Patients with conditions predisposing to peripheral neuropathy symptoms (e.g., alcoholism, uremia, diabetes, autoimmune disorders, rheumatoid arthritis, cervical spondylosis, severe mental illness, severe trauma);
5. Patients with Raynaud's syndrome, cold intolerance, peripheral arterial ischemia, or hand-foot syndrome;
6. Patients receiving medications that may mask CIPN symptoms (e.g., SSNRI, SSRI, tricyclic antidepressants, B-complex vitamins);
7. Patients with lymphedema in acupuncture stimulation areas;
8. Patients with phobia of electroacupuncture or stainless steel needle allergy;
9. Patients with severe non-malignant conditions that may compromise treatment adherence or pose risks;
10. Patients undergoing concurrent anti-tumor therapy or clinical trials;
11. Patients with dementia, cognitive impairment, or psychiatric conditions affecting informed consent comprehension;
12. Patients with known allergy history or contraindications to trial procedures;
13. 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;
14. Cardiac pacemaker implantation;
15. Known hereditary or acquired bleeding/thrombosis predispositions (e.g., hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.).

Where this trial is running

Guangzhou, Guangdong

• Breast Tumor Center, Sun Yat-sen Memorial Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Jieqiong Liu

Conditions Breast Cancer; Chemotherapy-induced Peripheral Neuropathy