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A Study on Electroacupuncture Combined With Olanzapine-contained Four-drug Antiemetic Therapy for the Prevention of Highly Emetogenic Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer
Led by Jiuda Zhao · Updated on 2025-04-02
370
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of electroacupuncture combined with olanzapine-containing standard quadruple antiemetic drugs to prevent nausea and vomiting caused by highly emetogenic chemotherapy (HEC) in patients with breast cancer. This phase III randomized controlled trial also aims to explore the relationship between genetic variations and the effectiveness of electroacupuncture treatment for chemotherapy-induced nausea and vomiting. Participants are randomly assigned to one of two groups: one group receives electroacupuncture once daily from day 1 to day 4 alongside standard antiemetic drugs including olanzapine, fosaprepitant or aprepitant, palonosetron or ondansetron or tropisetron, and dexamethasone. The other group receives sham acupuncture without electrical stimulation combined with the same standard antiemetic regimen. Electroacupuncture involves needle insertion and electrical stimulation for 30 minutes at specific acupoints, while sham acupuncture uses shallow needle insertion at non-acupuncture points without electrical stimulation. During the study, participants will record all episodes of nausea and vomiting and any use of rescue antiemetic medications. Blood samples will be collected to study genetic factors that may influence treatment response. Researchers will assess nausea control at different time stages up to 120 hours after chemotherapy, along with quality of life, insomnia, fatigue, constipation, and any side effects related to electroacupuncture. The study includes careful monitoring of adverse events and lasts through the chemotherapy treatment period.
CONDITIONS
Brief Title
Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older and 75 years or younger
- Eastern Cooperative Oncology Group performance status of 0-2
- Diagnosed with breast cancer, any molecular type
- Early-stage patients must not have had prior chemotherapy
- Advanced-stage patients must be candidates for first-line chemotherapy and have declined neoadjuvant or adjuvant chemotherapy for over 3 months
- Scheduled to receive highly emetogenic chemotherapy based on anthracycline with cyclophosphamide or carboplatin (AUC≥4) or cisplatin
- Predicted life expectancy of at least 3 months
- Adequate bone marrow, kidney, and liver function
- Adequate contraception if premenopausal
- Provided written informed consent before enrollment
You will not qualify if you...
- Previously received chemotherapy
- Scheduled to receive any non-highly emetogenic chemotherapy on Day 1
- Scheduled to receive chemotherapy on days 2-4 after highly emetogenic chemotherapy
- Received or scheduled for radiation therapy to abdomen, pelvis, head, or neck within 1 week before Day 1 or between Days 1 to 5 in cycle 1
- Has symptomatic primary or metastatic central nervous system cancer causing nausea or vomiting
- Currently experiencing vomiting or grade 2 or greater nausea
- Significant medical or mental conditions
- Allergy to study drugs, antiemetics, or dexamethasone
- Significantly abnormal laboratory values (platelets, coagulation, neutrophils, liver or kidney tests)
- Pregnant or breastfeeding
- Inflammatory skin reaction
- Lymphedema in acupuncture area
- Fear of electroacupuncture or allergy to stainless steel needles
- Received acupuncture within 4 weeks before chemotherapy
- Currently using other antiemetic drugs or medications affecting nausea
- Severe diseases or predisposition to nausea such as gastrointestinal obstruction, peptic ulcer, hypercalcemia, or symptomatic brain metastasis
- Convulsive disorder requiring anticonvulsant treatment
- Chronic use of thioridazine
- Concurrent treatment with quinolone antibiotics
- History of chronic alcoholism
- Known arrhythmias, uncontrolled heart failure, or recent heart attack
- History of uncontrolled diabetes requiring insulin or oral medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 days
Participants receive electroacupuncture or sham electroacupuncture once daily from Day 1 to Day 4 combined with standard quadruple antiemetic drug therapy during highly emetogenic chemotherapy.
Daily visits for 4 days
Duration - Up to 5 days (120 hours) post-treatment
Participants document nausea, vomiting, and use of rescue medications. Blood samples are collected to study genetic predictors of treatment outcomes. Safety and side effects are assessed up to 120 hours after chemotherapy.
1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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