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

NCT07644533 | Not Yet Recruiting DMC

• 1 other identifier: AHQU-2026002
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Electroacupuncture; Chemotherapy; Advanced Cancer; Peripheral Neuropathy

Keywords

Chemotherapy; Advanced Cancer; Peripheral neuropathy; Electroacupuncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The incidence of CIPN at 3, 6, 9, and 12 months after the start of chemotherapy

  1 year

• The incidence of ≥ grade 3 sensory CIPN at 3, 6, 9, and 12 months after the start of chemotherapy

  1 year

• The incidence of ≥ grade 2 sensory CIPN at 3, 6, 9, and 12 months after the start of chemotherapy

  1 year

• The time of occurrence of all levels and levels 3 and above CIPN

  1 year

• EORTC-CIPN20 evaluation score

  1 year

Study Arms (2)

True electroacupuncture combined with true thumbtack needle group

EXPERIMENTAL

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; Device: True thumbtack needle

Sham electroacupuncture combined with sham thumbtack needle group

SHAM COMPARATOR

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; Device: Sham thumbtack needle

Interventions

True electroacupuncture DEVICE

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.

True electroacupuncture combined with true thumbtack needle group

Sham electroacupuncture DEVICE

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.

Sham electroacupuncture combined with sham thumbtack needle group

Sham thumbtack needle DEVICE

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.

Sham electroacupuncture combined with sham thumbtack needle group

True thumbtack needle DEVICE

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.

True electroacupuncture combined with true thumbtack needle group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Qinghai University: lead

Study Sites (1)

Qinghai University Affiliated Hospital

Xining, Qinghai, 810000, China

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Jiuda Zhao

CONTACT

869716162732; jiudazhao@126.com

Fuxing Zhao

CONTACT

18797349621; 18797349621@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Breast Disease Diagnosis and Treatment Center

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: June 12, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): May 25, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)