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

Last updated: March 19, 2024
Sponsor: Feixue Song
Overall Status: Active - Recruiting

Phase

3

Condition

Gastroparesis

Lactose Intolerance

Colic

Treatment

Antiemetic Therapy

Electroacupuncture

Sham electroacupuncture

Clinical Study ID

NCT06314906
SHLU-2024001
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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

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 malignancycausing nausea and/or vomiting.
  5. Experiencing ongoing vomiting or nausea of grade 2 or higher according to CommonTerminology 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 stainlesssteel needles.
  8. Received acupuncture treatments for any conditions within 8 weeks prior to HEC.

Study Design

Total Participants: 370
Treatment Group(s): 3
Primary Treatment: Antiemetic Therapy
Phase: 3
Study Start date:
March 07, 2024
Estimated Completion Date:
March 31, 2027

Study Description

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.

Connect with a study center

  • Second Hospital of Lanzhou University

    Lanzhou, Gansu 730000
    China

    Active - Recruiting

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