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

ConditionsElectroacupuncture Olanzapine-contained Four-drug Antiemetic Nausea and Vomiting

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorFeixue Song

About this trial

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 insights into optimizing supportive care strategies for patients with breast cancer undergoing intensive chemotherapy treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Electroacupuncture
Device
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
Antiemetic Therapy
Drug
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.
Sham electroacupuncture
Device
Participants assigned to this arm will receive sham electroacupuncture sessions daily from day 1 to day 4, mirroring the schedule of the experimental group
Antiemetic Therapy
Drug
They will also receive the same antiemetic medications as the experimental group.

Treatment groups

370 Participants

are divided into 2 treatment groups

Group A: True Acupuncture Combined with Antiemetic TherapyExperimental treatment 2 interventions

Group B: Antiemetic therapyPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

Proportion of Patients Free from Nausea Throughout Treatment

The proportion of patients experiencing no nausea is determined by those who register a score of 0 on the visual-analogue scale for nausea throughout the entirety of treatment, spanning from initiation of chemotherapy to 120 hours post-treatment.

Time frame

120 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Feixue Song

Lead sponsor

Lanzhou University Second Hospital

Sponsor institution

Source ClinicalTrials.gov

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