Electroacupuncture with Standard Antiemetic Treatment for Chemotherapy-Related Gastrointestinal Symptoms in Breast Cancer Patients
Led by Jiuda Zhao · Updated on 2026-07-10
388
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of electroacupuncture combined with standard quadruple antiemetic therapy on chemotherapy-induced gastrointestinal symptom clusters, including nausea, vomiting, poor appetite, and dry mouth, in patients with breast cancer. This phase 3, randomized, double-blind, sham-controlled trial aims to clarify the regulatory mechanisms of electroacupuncture through clinical research, multi-omics analyses, and genomic studies to support optimized treatment strategies for managing these symptoms.
Participants receive either true electroacupuncture or sham electroacupuncture alongside a standard antiemetic regimen consisting of olanzapine, dexamethasone, a 5-HT3 receptor antagonist, and an NK-1 receptor antagonist. Electroacupuncture is applied at four specific points with continuous electrical stimulation before chemotherapy on day 1 and daily for three more days. The control group receives sham acupuncture with superficial needle insertion and inactive electrical stimulation on the same schedule.
Throughout days 1 to 5 of each chemotherapy cycle, researchers monitor gastrointestinal symptoms, collect weight, performance status, quality of life questionnaires, medication use, adverse events, and laboratory tests. Blood samples are preserved every two cycles. The main outcome is the incidence of gastrointestinal symptom clusters within 120 hours after chemotherapy, along with secondary measures including symptom improvements and quality of life, with systematic safety evaluations continuing through the study duration.
CONDITIONS
Brief Title
Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer
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Radiologically and pathologically confirmed stage I-III breast cancer
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1
Age between 18 and 75 years
Scheduled to receive highly emetogenic chemotherapy regimens, such as EC (epirubicin + cyclophosphamide) or platinum-based regimens, during the first cycle of neoadjuvant/adjuvant chemotherapy
No prior acupuncture treatment within one month before enrollment
Voluntary participation with written informed consent
Expected survival of at least 3 months
Premenopausal women must agree to use contraception during the study period
Adequate bone marrow, liver, and kidney function as defined by standard laboratory criteria
You will not qualify if you...
Advanced-stage cancer
Concurrent chemoradiotherapy
Severe impairment of vital organ function preventing tolerance of standard-dose chemotherapy
Contraindications to acupuncture, such as active skin infections
Digestive system diseases with nausea and vomiting symptoms that may interfere with assessments
History of xerostomia
Known allergies to study drugs
Pregnant or breastfeeding patients
Current use of medications with antiemetic activity (except physiological doses of corticosteroids or nighttime sedation)
Use of thiazides as chronic antipsychotic medications
Known arrhythmias, uncontrolled congestive heart failure, or recent acute myocardial infarction
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 days per chemotherapy cycle
Participants receive either true electroacupuncture or sham electroacupuncture combined with a standard quadruple antiemetic regimen during each chemotherapy cycle. Electroacupuncture or sham sessions occur once 1-2 hours before chemotherapy on Day 1 and daily on Days 2 to 4.
Daily visits during Days 1 to 4 of chemotherapy
Assessment and Follow-up
Duration - 5 days per chemotherapy cycle
Researchers monitor symptoms, collect questionnaires, record medication use and adverse events, perform laboratory tests, and preserve blood samples every two cycles. Quality of life and symptom assessments continue through day 5 of each cycle.
Visits and assessments on Days 1 to 5 of chemotherapy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer: Study Protocol for a Randomized Controlled Trial.