Acupuncture and Compression for the Prevention of CIPN in Breast Cancer Patients
Recruiting · NCT07377279 · Interventional (participants receive a specific treatment) · Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.).
Where it is running
1 location listed.
- Breast Tumor Center, Sun Yat-sen Memorial Hospital - Guangzhou, Guangdong, China