Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer

Inclusion criteria

• Aged 18 years or older and aged 75 years or younger, of any nationality;
• Eastern Cooperative Oncology Group performance status of 0-2;
• Patients with breast cancer, with no restrictions on molecular typing; early-stage patients must not have undergone prior chemotherapy, while advanced-stage patients must be candidates for first-line chemotherapy and have declined neoadjuvant or adjuvant chemotherapy for over 3 months. All patients must receive highly emetogenic chemotherapy (HEC) based on anthracycline chemotherapy with cyclophosphamide (EC or AC) or carboplatin (AUC≥4)/cisplatin;
• Predicted life expectancy of ≥3 months;
• Adequate bone marrow, kidney, and liver function;
• Adequate contraception if premenopausal women;
• Written informed consent by the patient before enrolment.

Exclusion criteria

• Patients already submitted to chemotherapy;
• Is scheduled to receive any non-HEC on Day 1;
• Is scheduled to receive any chemotherapy on days 2-4 after HEC;
• Received or is scheduled to receive radiation therapy to the abdomen, pelvis, head and neck within 1 week prior to Day 1 or between Days 1 to 5 in cycle 1;
• Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting;
• Have ongoing emesis or CTCAE grade 2 or greater nausea;
• Significant medical or mental conditions;
• Any allergies to study drug, antiemetics or dexamethasone;
• Significantly abnormal laboratory values (platelets, coagulation indexes, absolute neutrophils, AST, ALT, bilirubin or creatinine);
• Patients who are pregnant or breast-feeding;
• Inflammatory skin reaction;
• Has lymphedema in acupuncture stimulation area;
• Patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles;
• Received acupuncture treatments for any conditions less than 4 weeks before HEC;
• Currently using drugs with antiemetic activity (e.g., 5-HT3 receptor antagonists, corticosteroids (except when used at physiological doses), dopamine receptor antagonists, minor tranquilizers, antihistamines, and benzodiazepines (except for nocturnal sedation));
• Patients with concomitant severe diseases or with a predisposition to emesis such as gastrointestinal obstruction, active peptic ulcer, and hypercalcemia and symptomatic brain metastasis;
• Has a convulsive disorder requiring anticonvulsant treatment;
• Patients administered thioridazine as a chronic antipsychotic medication (patients are allowed to receive prochlorperazine and other phenothiazines as a rescue antiemetic treatment);
• Concurrent treatment with quinolone antibiotics;
• Has a history of chronic alcoholism (determined by the investigator);
• Known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction within the past six months;
• Has a history of uncontrolled diabetes (e.g., using insulin or oral hypoglycemic agents).