💬In plain words
What the trial is, and whether it could suit you
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 recomm
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.).