Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Electroacupuncture, Olanzapine-contained Four-drug Antiemetic, Nausea and Vomiting
In brief
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.
Key facts
- Study ID
- NCT06314906
- Run by
- Feixue Song
- People needed
- 370
- Starts
- 2024-03-07
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2024-03-21
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Second Hospital of Lanzhou University — Lanzhou, Gansu, China (enrolling)
Full record on ClinicalTrials.gov
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