Electroacupuncture for Preventing Chemotherapy-Induced Peripheral Neuropathy in Patients With Advanced Cancer

Официальное название

Electroacupuncture for Preventing Chemotherapy-Induced Peripheral Neuropathy in Patients With Advanced Cancer: A Randomized Controlled Clinical Trial

Обзор

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 advanced 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.

Подробное описание

A prospective, multicenter, block-randomized, blinded study design will be adopted. The study will screen patients with advanced 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.

Вмешательства

• Устройство True electroacupuncture
  The acupoints Zusanli, Hegu, Taichong, Quchi, and Yanglingquan will be selected for treatment. After inserting the needle with a 'deqi', electrodes will be connected bilaterally as follows: Quchi to Yanglingquan, and Hegu to Zusanli. The electroacupuncture parameters adopt a sparse wave type, with a frequency of 2/10Hz and a current intensity not exceeding 10mA. The treatment time is 30 minutes, based on the patient's tolerance.
• Устройство True thumbtack needle
  The Zusanli, Hegu, and Taichong on both sides will be selected for thumbtack needle therapy, clean the skin with a 75% alcohol cotton swab, and quickly insert the thumbtack needle into the skin and into the selected acupoints. On the day of thumbtack needle therapy, patients will be instructed to press each thumbtack for one minute at 9:00, 13:00, and 17:00, to induce a mild sensation of soreness and fullness. If fainting or skin allergies occur during the thumbtack needle therapy, the thumbtack
• Устройство Sham electroacupuncture
  Select Zusanli, Hegu, Taichong, Quchi, and Yanglingquan on both sides will be selected for sham electroacupuncture therapy, select 1-2cm near the Zusanli, Hegu, Taichong, Quchi, and Yanglingquan acupoints, shallow subcutaneous puncture, no electricity, 30 minutes.
• Устройство Sham thumbtack needle
  Select Zusanli, Hegu, and Taichong on both sides will be selected for sham thumbtack needle therapy. Select 1-2cm near the Zusanli, Hegu, and Taichong acupoints on both sides and apply sham thumbtack needle (remove the needle tip) without pressing.

Первичные конечные точки

• The incidence of CIPN during chemotherapy (from the beginning of chemotherapy to the end of chemotherapy for any reason) . [Срок оценки: 1 year]

Вторичные конечные точки (6)

• The incidence of CIPN at 3, 6, 9, and 12 months after the start of chemotherapy [Срок оценки: 1 year]
• The incidence of ≥ grade 3 sensory CIPN at 3, 6, 9, and 12 months after the start of chemotherapy [Срок оценки: 1 year]
• The incidence of ≥ grade 2 sensory CIPN at 3, 6, 9, and 12 months after the start of chemotherapy [Срок оценки: 1 year]
• The time of occurrence of all levels and levels 3 and above CIPN [Срок оценки: 1 year]
• EORTC-CIPN20 evaluation score [Срок оценки: 1 year]
• EQ-5D-5L evaluation score [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Pathological and imaging examinations confirmed the diagnosis of advanced cancer(IV 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 1.
• 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. NSCLC 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 (ULN); 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.

Критерии исключения

• Patients with early-stage 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Qinghai University Affiliated Hospital — Xining

Идентификаторы

NCT: NCT07644533 · AHQU-2026002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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