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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiuda Zhao | Contact | 869716162732 | jiudazhao@126.com | |
| Fuxing Zhao | Contact | 18797349621 | 18797349621@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qinghai University Affiliated Hospital | Xining | Qinghai | 810000 | China |
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| 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. |
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| 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. |
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| 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. |
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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 |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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