Acupuncture and Compression for the Prevention of CIPN in Breast Cancer Patients (NCT07377279) | Clinical Trial Compass
RecruitingNot Applicable
Acupuncture and Compression for the Prevention of CIPN in Breast Cancer Patients
China384 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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);
Exclusion criteria
✕. Patients with active infections, skin lesions on hands/feet, or contraindications to chemotherapy, acupuncture, or compression therapy;
What they're measuring
1
Incidence of grade ≥2 CIPN at 12 weeks after the initiation of chemotherapy
Timeframe: 12 weeks after the initiation of chemotherapy
Trial details
NCT IDNCT07377279
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University