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Electroacupuncture for Preventing Chemotherapy-Induced Peripheral Neuropathy in Patients With Early-stage Cancer
Condition(s) studied
ElectroacupunctureChemotherapyPeripheral NeuropathyEarly Stage Cancer
Investigational drug(s) / intervention(s)
True electroacupunctureTrue thumbtack needleSham electroacupunctureSham thumbtack needle
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.
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. At 9:00, 13:00, 17:00, and 21:00, patients will be instructed to press each acupoint for one minute, with pressure adjusted to a tolerable level of mild pain or achin. If fainting or skin allergies occur during the thumbtack needle therapy, the thumbtack needle will be promptly removed.
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.
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.
Study 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 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.
Eligibility
Inclusion Criteria:
* 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 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. 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- The incidence of CIPN during chemotherapy (from the beginning of chemotherapy to the end of chemotherapy for any reason) . — 1 year
The number of cases of CIPN occurring during chemotherapy/Total number of cases
Trial sites (1)
| Facility | City | Region | Status |
| Qinghai University Affiliated Hospital |
Xining |
Qinghai |
|
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