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-stagepatients must not have undergone prior chemotherapy, while advanced-stage patientsmust be candidates for first-line chemotherapy and have declined neoadjuvant oradjuvant chemotherapy for over 3 months. All patients must receive highly emetogenicchemotherapy (HEC) based on anthracycline chemotherapy with cyclophosphamide (EC orAC) 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, headand 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 malignancycausing 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, absoluteneutrophils, 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 stainlesssteel 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 receptorantagonists, minor tranquilizers, antihistamines, and benzodiazepines (except fornocturnal sedation));

16. Patients with concomitant severe diseases or with a predisposition to emesis such asgastrointestinal obstruction, active peptic ulcer, and hypercalcemia and symptomaticbrain metastasis;

17. Has a convulsive disorder requiring anticonvulsant treatment;

18. Patients administered thioridazine as a chronic antipsychotic medication (patientsare allowed to receive prochlorperazine and other phenothiazines as a rescueantiemetic 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 myocardialinfarction within the past six months;

22. Has a history of uncontrolled diabetes (e.g., using insulin or oral hypoglycemicagents).