Advanced Cancer, Chemotherapy, Electroacupuncture, Peripheral Neuropathy
Conditions
Keywords
Chemotherapy, Advanced Cancer, Peripheral neuropathy, Electroacupuncture
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.
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.
Interventions
DEVICETrue 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.
DEVICETrue 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.
DEVICESham 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.
DEVICESham 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.
Sponsors
Affiliated Hospital of Qinghai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of CIPN at 3, 6, 9, and 12 months after the start of chemotherapy | 1 year | 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 | 1 year | 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 | 1 year | 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 | 1 year | The time of occurrence of all levels and levels 3 and above CIPN |
| EORTC-CIPN20 evaluation score | 1 year | 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. |
| EQ-5D-5L evaluation score | 1 year | 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. |
Countries
China
Contacts
CONTACTJiuda Zhao
CONTACTFuxing Zhao
Outcome results
None listed