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.
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.
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.
Parallel
True electroacupuncture
DeviceThe 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
DeviceThe 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
DeviceSelect 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
DeviceSelect 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.
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
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
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
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
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
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
