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

Inclusion Criteria:

1. Aged 18 years or older and aged 75 years or younger, of any nationality;
2. Eastern Cooperative Oncology Group performance status of 0-2;
3. 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;
4. Predicted life expectancy of ≥3 months;
5. Adequate bone marrow, kidney, and liver function;
6. Adequate contraception if premenopausal women;
7. Written informed consent by the patient before enrolment.

Exclusion Criteria:

1. Patients already submitted to chemotherapy;
2. Is scheduled to receive any non-HEC on Day 1;
3. Is scheduled to receive any chemotherapy on days 2-4 after HEC;
4. 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;
5. Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting;
6. Have ongoing emesis or CTCAE grade 2 or greater nausea;
7. Significant medical or mental conditions;
8. Any allergies to study drug, antiemetics or dexamethasone;
9. Significantly abnormal laboratory values (platelets, coagulation indexes, absolute neutrophils, AST, ALT, bilirubin or creatinine);
10. Patients who are pregnant or breast-feeding;
11. Inflammatory skin reaction;
12. Has lymphedema in acupuncture stimulation area;
13. Patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles;
14. Received acupuncture treatments for any conditions less than 4 weeks before HEC;
15. 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));
16. Patients with concomitant severe diseases or with a predisposition to emesis such as gastrointestinal obstruction, active peptic ulcer, and hypercalcemia and symptomatic brain metastasis;
17. Has a convulsive disorder requiring anticonvulsant treatment;
18. Patients administered thioridazine as a chronic antipsychotic medication (patients are allowed to receive prochlorperazine and other phenothiazines as a rescue antiemetic treatment);
19. Concurrent treatment with quinolone antibiotics;
20. Has a history of chronic alcoholism (determined by the investigator);
21. Known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction within the past six months;
22. Has a history of uncontrolled diabetes (e.g., using insulin or oral hypoglycemic agents).