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

10 de junio de 2026 actualizado por: Jiuda Zhao, Affiliated Hospital of Qinghai University

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

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

264

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jiuda Zhao
  • Número de teléfono: 869716162732
  • Correo electrónico: jiudazhao@126.com

Copia de seguridad de contactos de estudio

  • Nombre: Fuxing Zhao
  • Número de teléfono: 18797349621
  • Correo electrónico: 18797349621@163.com

Ubicaciones de estudio

    • Qinghai
      • Xining, Qinghai, Porcelana, 810000
        • Qinghai University Affiliated Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: True electroacupuncture combined with true thumbtack needle group
Electroacupuncture will be administered on days 1, 2 and 3 of chemotherapy, followed by thumbtack needle therapy on days 4, 5, and 6 of chemotherapy, and no intervention will be given at other times. For electroacupuncture, we will choose the following acupoints: Zusanli, Hegu, Taichong, Quchi, and Yanglingquan. After achieving 'deqi', electrodes will be connected bilaterally as follows: Quchi to Yanglingquan, and Hegu to Zusanli. Stimulation will be delivered at 2/10Hz with a current of ≤10mA for 30 minutes. For thumbtack needle therapy, bilateral Zusanli, Hegu, and Taichong points will be sterilized with 75% alcohol before inserting and embedding the thumbtack needles. 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. The electroacupuncture and thumbtack needle therapy will be given for each chemotherapy cycle.
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.
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 needle will be promptly removed.
Comparador falso: Sham electroacupuncture combined with sham thumbtack needle group
Sham electroacupuncture will be administered on days 1, 2, and 3 of chemotherapy, followed by sham thumbtack needle therapy on days 4, 5, and 6 of chemotherapy, and no intervention will be given at other times. Sham electroacupuncture operation: Select the same acupoints as the experimental group, select 1-2cm near the Zusanli, Hegu, Taichong, Quchi, and Yanglingquan acupoints, shallow subcutaneous puncture, no electricity, 30 minutes. Sham thumbtack needle operation: Select 1-2cm near the Zusanli, Hegu, and Taichong acupoints on both sides to apply fake snap needles(remove the needle tip) without pressing. The same sham electroacupuncture and sham thumbtack needle therapy will be given for each chemotherapy cycle.
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The incidence of CIPN during chemotherapy (from the beginning of chemotherapy to the end of chemotherapy for any reason) .
Periodo de tiempo: 1 year
The number of cases of CIPN occurring during chemotherapy/Total number of cases
1 year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The incidence of CIPN at 3, 6, 9, and 12 months after the start of chemotherapy
Periodo de tiempo: 1 year
Number of CIPN cases at 3, 6, 9, and 12 months after the start of chemotherapy/Total number of cases
1 year
The incidence of ≥ grade 3 sensory CIPN at 3, 6, 9, and 12 months after the start of chemotherapy
Periodo de tiempo: 1 year
Number of cases of ≥ grade 3 sensory CIPN occurring at 3, 6, 9, and 12 months after the start of chemotherapy/Total number of cases
1 year
The incidence of ≥ grade 2 sensory CIPN at 3, 6, 9, and 12 months after the start of chemotherapy
Periodo de tiempo: 1 year
Number of cases of ≥ grade 2 sensory CIPN occurring at 3, 6, 9, and 12 months after the start of chemotherapy/Total number of cases
1 year
The time of occurrence of all levels and levels 3 and above CIPN
Periodo de tiempo: 1 year
The time of occurrence of all levels and levels 3 and above CIPN
1 year
EORTC-CIPN20 evaluation score
Periodo de tiempo: 1 year
The scale consists of 20 questions, each divided into 4 levels: 1 point: completely none, 2 points: a little, 3 points: quite a lot, 4 points: very much. The total score is converted into a standard rating score (0-100 points) through linear conversion, and there is only one unit of score.
1 year
EQ-5D-5L evaluation score
Periodo de tiempo: 1 year

For the Descriptive System(Health State Index): A single summary index value(often called a 'utility' score) is calculated by applying a country-specific or region-specific value set(or 'tariff') to the 5-digit health state code. These value sets, derived from general population studies, assign weights to each possible health state. The index typically ranges from values less than 0(where 0=dead, and states worse than dead have negative values) to 1(full health). There is no single global scoring formula; the appropriate national value set must be used.

For the EQ VAS: The score is the self-reported number between 0 and 100, representing the respondent's perception of their overall health at that moment. It is reported as a raw score, and there is only one unit of score.

1 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

25 de mayo de 2026

Finalización primaria (Estimado)

25 de mayo de 2029

Finalización del estudio (Estimado)

31 de julio de 2029

Fechas de registro del estudio

Enviado por primera vez

15 de febrero de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de junio de 2026

Publicado por primera vez (Actual)

12 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • AHQU-2026002

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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