Actively Recruiting
Acupuncture and Compression for the Prevention of CIPN in Breast Cancer Patients
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-02-02
384
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Acupuncture and Compression for the Prevention of CIPN in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old with signed informed consent
- Histologically confirmed non-recurrent early or intermediate-stage breast cancer
- Scheduled to receive cyclical adjuvant or neoadjuvant taxane-based chemotherapy (4-cycle or single-cycle regimen)
- No prior chemotherapy, immunotherapy, or endocrine therapy for breast cancer
- Normal cardiac ejection fraction by echocardiography
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No psychiatric or cognitive impairments and able to complete assessment scales
- No chemotherapy-induced peripheral neuropathy at baseline (NCI-CTCAE 5.0 and TNSc grade 0)
- Good organ function meeting specified blood count and liver/kidney function criteria
- Fertile women must agree to use effective contraception and have a negative pregnancy test before first dosing
You will not qualify if you...
- Active infections, skin lesions on hands or feet, or contraindications to chemotherapy, acupuncture, or compression therapy
- Previous exposure to neurotoxic agents such as taxanes, oxaliplatin, platinum drugs, or vincristine
- Acupuncture treatment within the past month for other conditions
- Conditions causing peripheral neuropathy symptoms like alcoholism, uremia, diabetes, autoimmune disorders, rheumatoid arthritis, cervical spondylosis, severe mental illness, or trauma
- Raynaud's syndrome, cold intolerance, peripheral arterial ischemia, or hand-foot syndrome
- Taking medications that may mask peripheral neuropathy symptoms (e.g., SSNRI, SSRI, tricyclic antidepressants, B-complex vitamins)
- Lymphedema in acupuncture areas
- Phobia of electroacupuncture or allergy to stainless steel needles
- Severe non-malignant conditions affecting treatment adherence or safety
- Concurrent anti-tumor therapies or participation in other clinical trials
- Dementia, cognitive impairment, or psychiatric conditions affecting consent
- Known allergies or contraindications to study procedures
- Uncontrolled cardiac conditions including NYHA class 2 or higher heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
- Cardiac pacemaker implantation
- Known bleeding or clotting disorders such as hemophilia, thrombocytopenia, or hypersplenism
AI-Screening
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Trial Site Locations
Total: 1 location
1
Breast Tumor Center, Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
J
Jieqiong Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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