Acupuncture and Compression for the Prevention of Peripheral Neuropathy Induced by Taxane-based Chemotherapy in Breast Cancer Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Incidence of grade ≥2 CIPN at 12 weeks after the initiation of chemotherapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
- •Good organ function meeting the following criteria: Hb ≥90g/L, WBC ≥3.5×10⁹/L, platelets ≥100×10⁹/L, neutrophils ≥1.5×10⁹/L, AST ≤3× upper limit of normal, ALT ≤3× upper limit of normal, bilirubin ≤1.5× upper limit of normal, serum creatinine ≤1.5× upper limit of normal;
- •Fertile women must agree to use effective contraception for 7 days before first dosing through 24 weeks post-treatment. Fertile women must have a negative serum pregnancy test within 7 days before first dosing.
排除标准
- •Patients with active infections, skin lesions on hands/feet, or contraindications to chemotherapy, acupuncture, or compression therapy;
- •Patients with prior exposure to neurotoxic agents (e.g., taxanes, oxaliplatin, platinum-based drugs, vincristine) or platinum-containing chemotherapy regimens;
- •Patients who received acupuncture for other conditions within the past month;
- •Patients with conditions predisposing to peripheral neuropathy symptoms (e.g., alcoholism, uremia, diabetes, autoimmune disorders, rheumatoid arthritis, cervical spondylosis, severe mental illness, severe trauma);
- •Patients with Raynaud's syndrome, cold intolerance, peripheral arterial ischemia, or hand-foot syndrome;
- •Patients receiving medications that may mask CIPN symptoms (e.g., SSNRI, SSRI, tricyclic antidepressants, B-complex vitamins);
- •Patients with lymphedema in acupuncture stimulation areas;
- •Patients with phobia of electroacupuncture or stainless steel needle allergy;
- •Patients with severe non-malignant conditions that may compromise treatment adherence or pose risks;
- •Patients undergoing concurrent anti-tumor therapy or clinical trials;
- •Patients with dementia, cognitive impairment, or psychiatric conditions affecting informed consent comprehension;
- •Patients with known allergy history or contraindications to trial procedures;
- •Patients with uncontrolled cardiac symptoms or conditions, including: (1) NYHA class 2 or higher heart failure; (2) unstable angina; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment;
- •Cardiac pacemaker implantation;
- •Known hereditary or acquired bleeding/thrombosis predispositions (e.g., hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.).
研究组 & 干预措施
Compression
Latex gloves and compression stockings are worn during chemotherapy.
干预措施: Compression (Other)
Acupuncture
Electroacupuncture treatment is administered after each chemotherapy cycle and continuing consecutively for 3-5 days.
干预措施: Acupuncture (Other)
Compression combined with acupuncture
Compression therapy will be administered during chemotherapy, combined with consecutive electroacupuncture for 3-5 days after each chemotherapy cycle.
干预措施: Compression combined with acupuncture (Other)
Sham acupuncture
A shallow needling at non-acupoint sites (sham acupuncture) is inserted superficially to a depth of 2-3 mm without manipulation.
干预措施: Sham acupuncture (Other)
结局指标
主要结局
Incidence of grade ≥2 CIPN at 12 weeks after the initiation of chemotherapy
时间窗: 12 weeks after the initiation of chemotherapy
The incidence of CIPN ≥ grade 2 is assessed according to the NCI-CTCAE v5.0 criteria.
次要结局
- Incidence of CIPN(6 and 12 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion)
- Incidence of grade ≥2 CIPN at 6 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion(6 weeks after chemotherapy initiation, 12 and 24 weeks after chemotherapy completion)
- Assessment of quality of life via the EORTC QLQ-C30 questionnaire.(Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy.)
- Assessment of sensation and motor function via the EORTC QLQ-CIPN20 questionnaire.(Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy.)
- Nail toxicity(Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy.)
- Objective neurological function(Every 6 weeks until the end of chemotherapy; 12 and 24 weeks after the end of chemotherapy.)
- Adverse event incidence rate(8 months (during taxane therapy and follow up).)
研究者
Jieqiong Liu, M.D., Ph.D.
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University