Electroacupuncture for Preventing Chemotherapy-Induced Peripheral Neuropathy in Patients With Early-stage Cancer: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 278
- 试验地点
- 1
研究概览
简要总结
This randomized controlled clinical trial aims to clarify the clinical efficacy and safety of electroacupuncture combined with thumbtack needle for the prevention of chemotherapy-induced peripheral neuropathy(CIPN), and to provide high-level evidence-based medicine for the prevention of CIPN in patients with early stage cancer. At the same time, the effects of electroacupuncture on the median nerve, tibial nerve, sural nerve sensory conduction velocity and sensory nerve action potential, as well as on the median nerve and tibial nerve motor conduction velocity will be analyzed.
详细描述
A prospective, multicenter, block-randomized, blinded study design will be adopted. The study will screen patients with early stage breast cancer, gastric cancer, intestinal cancer, non-small cell lung cancer, and ovarian cancer who are receiving chemotherapy. Eligible participants will be randomly assigned in a 1:1 ratio, through a screening and informed consent process, to either the experimental group or the control group. The experimental group will receive electroacupuncture combined with thumbtack needle treatment, while the control group will receive sham electroacupuncture combined with sham thumbtack needle treatment. The primary endpoint will be the incidence of CIPN during chemotherapy(assessed by NCI-CTCAE). Secondary endpoints will include: the incidence of CIPN at 3, 6, and 9 months after the start of chemotherapy; the incidence of ≥ grade 3 sensory CIPN within 3, 6, 9, and 12 months after the start of chemotherapy; and the incidence of ≥ grade 2 sensory CIPN within 3, 6, 9, and 12 months after the start of chemotherapy. Simultaneously evaluate the safety of treatment and the quality of life of patients. Changes in nerve conduction velocity will be detected before the first cycle of chemotherapy and after the fourth cycle of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Pathological and imaging examinations confirmed the diagnosis of early-stage cancer(I-III stage), including: breast cancer, gastric cancer, intestinal cancer, non-small cell lung cancer or ovarian cancer.
- •Eastern Cooperative Oncology Group Performance Status of 0 or
- •Scheduled to receive chemotherapy containing a taxane, utidelone, or oxaliplatin, with no significant pre-existing neurological symptoms prior to chemotherapy. Specific regimens include: Colorectal cancer: Oxaliplatin-containing regimen. Gastric cancer: Oxaliplatin-containing or taxane-containing regimen. Breast cancer: Taxane-containing or utidelone-containing regimen. Non small cell lung cancer or Ovarian cancer: Taxane-containing regimen.
- •No history of acupuncture treatment within one month prior to study initiation.
- •Adequate major organ function, meeting the following laboratory criteria: Hematology: Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; White blood cell count 3.5 - 9.5 × 10^9/L; Hemoglobin ≥ 100 g/L. Hepatic Function: Total bilirubin ≤ 1.5 × upper limit of normal; Aspartate aminotransferase and alanine aminotransferase ≤ 3 × ULN; Serum bilirubin concentration < 1.5 mg/dL; Serum albumin > 2.5 g/dL. Renal Function: Serum creatinine ≤ 1.5 × ULN, OR calculated creatinine clearance ≥ 50 mL/min (using the Cockcroft-Gault formula). Coagulation: International normalized ratio ≤ 1.5, AND activated partial thromboplastin time ≤ 1.5 × ULN.
- •Willing to receive acupuncture intervention and undergo subsequent follow-up assessments.
- •Voluntarily agree to participate in the study and sign an informed consent form.
排除标准
- •Patients with advanced cancer.
- •Pre-existing peripheral neuropathy prior to the initiation of chemotherapy.
- •Severe impairment of major organ function, rendering the patient unable to tolerate standard-dose chemotherapy.
- •Presence of active skin infection or other conditions unsuitable for acupuncture treatment.
- •Coexisting underlying diseases associated with peripheral neuropathy, such as diabetes mellitus, Guillain-Barré syndrome, or chronic inflammatory demyelinating polyradiculoneuropathy.
- •Current use of medications for neuropathic pain (e.g., gabapentin, pregabalin).
- •Pregnant or lactating patients.
- •Presence of dermatological conditions, as assessed by the clinician, that may interfere with the study procedures or outcomes.
- •Patients with active brain metastases.
- •Patients with a history of implanted cardiac pacemakers or defibrillators, or a history of epilepsy.
研究者
Jiuda Zhao
Breast Disease Diagnosis and Treatment Center
Affiliated Hospital of Qinghai University