Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer
Recruiting · NCT06314906 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Second Hospital of Lanzhou University - Lanzhou, Gansu, China