RecruitingNot ApplicableNCT07377279

Acupuncture and Compression for the Prevention of CIPN in Breast Cancer Patients

Acupuncture and Compression for the Prevention of Peripheral Neuropathy Induced by Taxane-based Chemotherapy in Breast Cancer Patients: A Randomized Controlled Trial


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

384 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether acupuncture combined with compression therapy can prevent chemotherapy-induced peripheral neuropathy (CIPN) — nerve damage in the hands and feet — in breast cancer patients undergoing taxane-based chemotherapy. **You may be eligible if...** - You are 18–70 years old with confirmed early or intermediate-stage breast cancer (not recurrent) - You are scheduled to receive taxane-based chemotherapy (a common breast cancer drug) - You have not had prior chemotherapy or other anti-cancer treatments for breast cancer - You have no current nerve damage in your hands or feet - Your blood counts, liver, and kidney function are within normal ranges **You may NOT be eligible if...** - You have active infections, skin lesions on hands or feet, or prior nerve-damaging chemotherapy - You have diabetes, rheumatoid arthritis, alcoholism, or other conditions that cause peripheral neuropathy - You have lymphedema, Raynaud's syndrome, or cold intolerance in the arms - You take medications that might hide nerve damage symptoms (such as certain antidepressants) - You have a cardiac pacemaker or are allergic to stainless steel needles - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCompression

Two layers of latex gloves are worn on both hands, and Class II compression stockings are worn on both feet. The devices are donned 30 minutes before chemotherapy initiation and removed 30 minutes after chemotherapy completion.

OTHERAcupuncture

Acupuncture is administered consecutively for 3-5 days starting from Day 1 post each chemotherapy cycle, with electrical stimulation applied for 20-30 minutes per session. The selected acupoints included: PC6, LI4, SI3, ST36, SP6, LR3, SP4, EX-LE10.

OTHERSham acupuncture

A shallow needling at non-acupoint sites (sham acupuncture) is adopted. The stimulation locations are non-acupoint areas 1-2 cun away from the standard acupoint positions. For the sham acupuncture group, needles are inserted superficially to a depth of 2-3 mm without manipulation, with the endpoint of no deqi sensation. Operational elements including needle type, patient posture, disinfection method, needle insertion technique, needle retention time, and needle withdrawal technique are identical between the sham acupuncture group and the active acupuncture group.

OTHERCompression combined with acupuncture

Two layers of latex gloves are worn on both hands, and Class II compression stockings are worn on both feet. The devices are donned 30 minutes before chemotherapy initiation and removed 30 minutes after chemotherapy completion. Acupuncture is administered consecutively for 3-5 days starting from Day 1 post each chemotherapy cycle, with electrical stimulation applied for 20-30 minutes per session. The selected acupoints included: PC6, LI4, SI3, ST36, SP6, LR3, SP4, EX-LE10.


Locations(1)

Breast Tumor Center, Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

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NCT07377279


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