What is this study trying to find out about chemotherapy-induced peripheral neuropathy in breast cancer patients?

This study is evaluating whether compression therapy, acupuncture, or their combination can prevent nerve damage caused by taxane chemotherapy in breast cancer patients. The goal is to find effective, non-drug ways to reduce symptoms and improve quality of life. It is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

Who may be eligible for this breast cancer clinical trial?

Adults aged 18 to 70 with early or intermediate-stage breast cancer scheduled for taxane-based chemotherapy may be eligible. Participants must not have had prior chemotherapy or nerve symptoms and need to have good heart and organ function. Both women and men can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this breast cancer clinical trial?

Study-related care, including the study treatments and all trial visits, is provided at no cost. Personal travel expenses vary by participant and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 70Years

All Genders

ID07377279

Preventing Peripheral Neuropathy in Breast Cancer Patients Receiving Taxane Chemotherapy Using Acupuncture and Compression Therapy A Randomized Study

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-02-02

384

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 18Years - 70Years

All Genders

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)

Research Team

Jieqiong Liu

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