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
Feixue Song
370 participants
Mar 7, 2024
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
Inclusion Criteria6
- 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 Criteria8
- 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.
Interventions
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
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06314906