Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer
NCT ID: NCT06314906
Last Updated: 2024-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
370 participants
INTERVENTIONAL
2024-03-07
2027-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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True Acupuncture Combined with Antiemetic Therapy
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.
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
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.
Antiemetic therapy
Participants assigned to this arm will receive sham electroacupuncture sessions daily from day 1 to day 4, mirroring the schedule of the experimental group. They will also receive the same antiemetic medications as the experimental group.
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
Antiemetic Therapy
They will also receive the same antiemetic medications as the experimental group.
Interventions
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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
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.
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
Antiemetic Therapy
They will also receive the same antiemetic medications as the experimental group.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
Yes
Sponsors
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Feixue Song
OTHER
Responsible Party
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Feixue Song
Professor
Locations
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Second Hospital of Lanzhou University
Lanzhou, Gansu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHLU-2024001
Identifier Type: -
Identifier Source: org_study_id
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