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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chemotherapy; Advanced Cancer; Peripheral Neuropathy; Electroacupuncture
• Intervention / Treatment: Device: True electroacupuncture; Device: True thumbtack needle; Device: Sham electroacupuncture; Device: Sham thumbtack needle

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiuda Zhao; Phone Number: 869716162732; Email: jiudazhao@126.com
• Study Contact Backup: Name: Fuxing Zhao; Phone Number: 18797349621; Email: 18797349621@163.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.; Device: 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 needle will be promptly removed.
Sham Comparator: 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.	Device: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of CIPN during chemotherapy (from the beginning of chemotherapy to the end of chemotherapy for any reason) .	The number of cases of CIPN occurring during chemotherapy/Total number of cases	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of CIPN at 3, 6, 9, and 12 months after the start of chemotherapy	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	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	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	The time of occurrence of all levels and levels 3 and above CIPN	1 year
EORTC-CIPN20 evaluation score	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	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

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Qinghai University

Study record dates

Study Major Dates

• Study Start (Estimated): May 25, 2026
• Primary Completion (Estimated): May 25, 2029
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: February 15, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Chemotherapy; Advanced Cancer; Peripheral neuropathy; Electroacupuncture
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: AHQU-2026002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No