RecruitingPhase 3NCT06314906

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

Combining Electroacupuncture With Antiemetic Therapy for Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer: A Clinical Study


Sponsor

Feixue Song

Enrollment

370 participants

Start Date

Mar 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding electroacupuncture (a form of acupuncture using gentle electrical stimulation on needles) to standard anti-nausea medications reduces chemotherapy-induced nausea and vomiting in women with early-stage breast cancer receiving highly emetogenic (strongly nausea-causing) chemotherapy. **You may be eligible if...** - You are between 18 and 75 years old and have been diagnosed with early-stage breast cancer - You are scheduled to receive highly emetogenic chemotherapy (a type of chemo regimen known to cause severe nausea) - Your general health is reasonable (ECOG 0–2) with adequate organ function - You are premenopausal and using adequate contraception, if applicable **You may NOT be eligible if...** - You are scheduled for additional chemotherapy on days 2–4 right after the first treatment - You have or are planned to receive abdominal radiation within 1 week before your first chemo cycle - You have significant medical or psychological conditions that could interfere with participation - You are already experiencing moderate-to-severe nausea or vomiting (grade 2 or higher) before starting chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEElectroacupuncture

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

DRUGAntiemetic 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.

DEVICESham 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

DRUGAntiemetic Therapy

They will also receive the same antiemetic medications as the experimental group.


Locations(1)

Second Hospital of Lanzhou University

Lanzhou, Gansu, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06314906


Related Trials