Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electroacupuncture, Antiemetic Therapy, Sham electroacupuncture, Antiemetic Therapy.
- Who it may be relevant to
- Registry conditions: Electroacupuncture, Olanzapine-contained Four-drug Antiemetic, Nausea and Vomiting. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Combining Electroacupuncture With Antiemetic Therapy for Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer: A Clinical Study
Overview
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.
Detailed 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.
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 outcome measures
- Proportion of Patients Free from Nausea Throughout Treatment [Time frame: 120 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Second Hospital of Lanzhou University — Lanzhou
Identifiers
NCT: NCT06314906 · SHLU-2024001