Acupuncture and Compression for the Prevention of CIPN in Breast Cancer Patients

Inclusion criteria

• 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;
• 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.

Exclusion criteria

• 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);
• 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.).