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

This study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer. The research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy regimens. By investigating the synergistic potential of these modalities, the study seeks to provide…

ClinicalTrials.gov IDNCT06314906

PhasePHASE3

Enrollment370

SponsorFeixue Song

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Electroacupuncture, Olanzapine-contained Four-drug Antiemetic, Nausea and Vomiting

About this study

Interventions

Device: Electroacupuncture — Participants in this arm will undergo electroacupuncture sessions once daily from day 1 to day 4. Electrical stimulation will be administered for 30 minutes at alternating frequencies of 2/10Hz
Drug: Antiemetic Therapy — Participants will receive oral olanzapine at a dose of 5 mg per day on days 1 through 4, along with NK1 receptor antagonist, 5HT3 receptor antagonist, and intravenous dexamethasone at a dose of 10 mg 30 minutes prior to chemotherapy on Day 1, followed by intravenous dexamethasone at a dose of 8 mg on days 2, 3, and 4 post-chemotherapy.
Device: Sham electroacupuncture — Participants assigned to this arm will receive sham electroacupuncture sessions daily from day 1 to day 4, mirroring the schedule of the experimental group
Drug: Antiemetic Therapy — They will also receive the same antiemetic medications as the experimental group.

Primary outcomes

Proportion of Patients Free from Nausea Throughout Treatment (120 hours)

Eligibility information

Inclusion Criteria: 1. Patients aged 18 to 75 years, inclusive, from any nationality. 2. Patients diagnosed with early-stage breast cancer. 3. Eastern Cooperative Oncology Group performance status ranging from 0 to 2. 4. All patients must undergo highly emetogenic chemotherapy (HEC). 5. Adequate organ function. 6. Adequate contraception required for premenopausal women. Exclusion Criteria: 1. Scheduled to undergo chemotherapy between days 2 to 4 following HEC. 2. Received or is planned to receive abdominal radiation therapy within 1 week before Day 1 in cycle 1. 3. Significant medical or psychological conditions. 4. Presents with symptomatic primary or metastatic central nervous system malignancy causing nausea and/or vomiting. 5. Experiencing ongoing vomiting or nausea of grade 2 or higher according to Common Terminology Criteria for Adverse Events (CTCAE). 6. Any known allergies to the study drug, antiemetics, or dexamethasone. 7. Patients who have fear of electroacupuncture stimulation or are allergic to stainless steel needles. 8. Received acupuncture treatments for any conditions within 8 weeks prior to HEC.

Study locations

Second Hospital of Lanzhou University, Lanzhou, Gansu 730000 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.