Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer

This study is a randomized controlled trial conducted in parallel groups, with blinding implemented. It aims to assess the effectiveness of combining electroacupuncture with standard quadruple antiemetic drugs for patients with breast cancer undergoing HEC.

Both study arms will be administered Olanzapine, Neurokinin-1 receptor antagonists, serotonin receptor antagonists, and dexamethasone at the commencement of HEC on Day 1. Subsequently, participants will be randomly assigned to receive either electroacupuncture or sham acupuncture.

Participants will be responsible for recording all instances of nausea and vomiting, as well as documenting the use of rescue antiemetic medications.

The study will evaluate primary and secondary outcomes, as well as monitor adverse events.

Inclusion criteria

• Patients aged 18 to 75 years, inclusive, from any nationality.
• Patients diagnosed with early-stage breast cancer.
• Eastern Cooperative Oncology Group performance status ranging from 0 to 2.
• All patients must undergo highly emetogenic chemotherapy (HEC).
• Adequate organ function.
• Adequate contraception required for premenopausal women.

Exclusion criteria

• Scheduled to undergo chemotherapy between days 2 to 4 following HEC.
• Received or is planned to receive abdominal radiation therapy within 1 week before Day 1 in cycle 1.
• Significant medical or psychological conditions.
• Presents with symptomatic primary or metastatic central nervous system malignancy causing nausea and/or vomiting.
• Experiencing ongoing vomiting or nausea of grade 2 or higher according to Common Terminology Criteria for Adverse Events (CTCAE).
• Any known allergies to the study drug, antiemetics, or dexamethasone.
• Patients who have fear of electroacupuncture stimulation or are allergic to stainless steel needles.
• Received acupuncture treatments for any conditions within 8 weeks prior to HEC.