Actively Recruiting
Electroacupuncture for the Prevention of 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
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 to 75 years
- Eastern Cooperative Oncology Group performance status of 0-2
- Diagnosed with breast cancer; 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
- Receiving highly emetogenic chemotherapy based on anthracycline with cyclophosphamide or carboplatin/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...
- Have already received chemotherapy
- Scheduled to receive non-highly emetogenic chemotherapy on Day 1
- Scheduled to receive chemotherapy on days 2-4 after HEC
- 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
- Have symptomatic primary or metastatic central nervous system cancer causing nausea or vomiting
- Have ongoing vomiting or grade 2 or greater nausea
- Significant medical or mental conditions
- Allergies to study drugs, antiemetics, or dexamethasone
- Significantly abnormal lab values (platelets, coagulation, neutrophils, liver enzymes, bilirubin, creatinine)
- Pregnant or breastfeeding
- Inflammatory skin reactions
- Lymphedema in acupuncture area
- Fear of electroacupuncture or allergy to stainless steel needles
- Received acupuncture within 4 weeks before HEC
- Currently using antiemetic drugs
- Severe diseases or conditions that cause vomiting such as gastrointestinal obstruction, peptic ulcer, hypercalcemia, or symptomatic brain metastasis
- Convulsive disorder requiring anticonvulsants
- Using thioridazine chronically
- Concurrent quinolone antibiotics
- History of chronic alcoholism
- Known arrhythmias, uncontrolled heart failure, or recent heart attack
- History of uncontrolled diabetes requiring medication
AI-Screening
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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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