Actively Recruiting
Acupuncture and Compression for the Prevention of Peripheral Neuropathy Induced by Taxane-based Chemotherapy in Breast Cancer Patients: A Randomized Controlled Trial
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-02-02
384
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and challenging side effect for breast cancer patients receiving taxane-based chemotherapy. It can cause long-lasting nerve symptoms that affect quality of life and may lead to changes or stopping of cancer treatment. Currently, there are no widely recommended preventive treatments, though compression therapy and acupuncture have shown promise. This trial aims to evaluate the preventive effects of compression therapy, acupuncture, and their combination to provide better evidence for tailored prevention strategies. Participants are randomly assigned to one of four groups: compression therapy alone, acupuncture alone, combined compression and acupuncture, or sham acupuncture as a placebo. Compression involves wearing latex gloves and compression stockings during chemotherapy sessions. Acupuncture is delivered electrically for 3 to 5 days after each chemotherapy cycle at specific acupoints. The combined group receives both compression during chemotherapy and acupuncture afterward. The sham group receives superficial needling at non-acupoint sites without stimulation. During the study, participants are monitored closely with regular assessments of nerve symptoms, motor and sensory function, quality of life, and nail toxicity at multiple time points during and after chemotherapy. Researchers also track any side effects related to the interventions over an 8-month period. The main measure is the occurrence of moderate or worse CIPN symptoms 12 weeks after starting chemotherapy. This study is designed to last from chemotherapy initiation through 24 weeks post-treatment to fully evaluate the interventions' effects and safety.
CONDITIONS
Brief Title
Acupuncture and Compression for the Prevention of CIPN in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old and signed informed consent
- Histologically confirmed non-recurrent early or intermediate-stage breast cancer
- Scheduled for 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) physical status 0 or 1
- No psychiatric or cognitive impairments, able to complete assessments
- No peripheral neuropathy at baseline (NCI-CTCAE 5.0 and TNSc grading 0)
- Good organ function meeting specified blood and liver/kidney test thresholds
- Fertile women 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
- Prior exposure to neurotoxic agents such as taxanes, oxaliplatin, platinum drugs, or vincristine
- Received acupuncture for other conditions within the past month
- Conditions causing peripheral neuropathy symptoms (e.g., alcoholism, diabetes, autoimmune disorders, rheumatoid arthritis, cervical spondylosis, severe mental illness, severe trauma)
- Raynaud's syndrome, cold intolerance, peripheral arterial ischemia, or hand-foot syndrome
- Taking medications that may mask neuropathy symptoms (e.g., SSNRI, SSRI, tricyclic antidepressants, B-complex vitamins)
- Lymphedema in acupuncture stimulation areas
- Phobia of electroacupuncture or allergy to stainless steel needles
- Severe non-cancer conditions that affect treatment adherence or increase risk
- Concurrent anti-tumor therapy or participation in other clinical trials
- Dementia, cognitive impairment, or psychiatric conditions affecting informed consent
- Known allergies or contraindications to study procedures
- Uncontrolled cardiac conditions, including heart failure (NYHA class 2 or higher), unstable angina, recent myocardial infarction, or significant arrhythmias
- Cardiac pacemaker implantation
- Known bleeding or clotting disorders (e.g., hemophilia, thrombocytopenia, hypersplenism)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks from chemotherapy initiation
Participants receive taxane-based chemotherapy with either compression therapy, acupuncture, compression combined with acupuncture, or sham acupuncture as preventive interventions to reduce chemotherapy-induced peripheral neuropathy (CIPN). Compression devices are worn on hands and feet during chemotherapy, and acupuncture is administered for 3-5 consecutive days after each chemotherapy cycle.
Visits during each chemotherapy cycle and acupuncture sessions for 3-5 days post chemotherapy
Duration - Up to 24 weeks after chemotherapy completion
Participants are monitored for the incidence and severity of CIPN, quality of life, neurological function, and adverse events up to 24 weeks after chemotherapy completion.
Approximately 4 visits post-chemotherapy over 24 weeks
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
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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