Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiuda Zhao
About this trial
This randomized controlled phase III trial aims to evaluate the use of electroacupuncture in combination with olanzapine-containing standard quadruple antiemetic drugs for the treatment of nausea and vomiting induced by highly emetogenic chemotherapy (HEC) in patients with breast cancer. Furthermore, it will analyze the relationship between single nucleotide polymorphism and electroacupuncture treatment for chemotherapy-induced nausea and vomiting.
Eligibility criteria
Qualifiers
Aged 18 years or older and aged 75 years or younger, of any nationality;
Eastern Cooperative Oncology Group performance status of 0-2;
Patients with breast cancer, with no restrictions on molecular typing; early-stage patients must not have undergone prior chemotherapy, while advanced-stage patients must be candidates for first-line chemotherapy and have declined neoadjuvant or adjuvant chemotherapy for over 3 months. All patients must receive highly emetogenic chemotherapy (HEC) based on anthracycline chemotherapy with cyclophosphamide (EC or AC) or carboplatin (AUC≥4)/cisplatin;
Predicted life expectancy of ≥3 months;
Disqualifiers
Patients already submitted to chemotherapy;
Is scheduled to receive any non-HEC on Day 1;
Is scheduled to receive any chemotherapy on days 2-4 after HEC;
Received or is scheduled to receive radiation therapy to the abdomen, pelvis, head and neck within 1 week prior to Day 1 or between Days 1 to 5 in cycle 1;
Trial design
Treatments tested in this trial
- Electroacupuncture
- Standard antiemetic treatment
- Sham electroacupuncture
- Standard antiemetic treatment
Treatment groups
370 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jiuda Zhao
Lead sponsor
Affiliated Hospital of Qinghai University
Sponsor institution
Source ClinicalTrials.gov