Status:
RECRUITING
Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer
Lead Sponsor:
Jiuda Zhao
Conditions:
Standard Quadruple Antiemetic Therapy
Electroacupuncture
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study aims to elucidate the therapeutic efficacy of electroacupuncture in managing chemotherapy-induced gastrointestinal symptom clusters through clinical research. Building upon this foundation,...
Detailed Description
This prospective, multicenter, randomized, double-blind, sham-controlled trial investigates the efficacy of electroacupuncture (EA) combined with standard quadruple antiemetic therapy (olanzapine + de...
Eligibility Criteria
Inclusion
- Pathologically confirmed stage I-III breast cancer;
- An 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 in the study with written informed consent obtained; (7) An expected survival of at least 3 months;
- (8) Premenopausal women must agree to use contraception during the study period; (9) Adequate bone marrow, liver, and kidney function as defined by standard laboratory criteria.
Exclusion
- Patients with advanced-stage cancer;
- Those undergoing concurrent chemoradiotherapy;
- Individuals with severe impairment of vital organ function who cannot tolerate standard-dose chemotherapy;
- Patients with contraindications to acupuncture, such as active skin infections;
- Those with digestive system diseases accompanied by nausea and vomiting symptoms that may interfere with accurate assessment;
- Patients with a history of xerostomia;
- Individuals with known allergies to the study drugs;
- Pregnant or breastfeeding patients;
- Individuals currently using medications with antiemetic activity, such as 5-HT3 receptor antagonists, corticosteroids (except at physiological doses), dopamine receptor antagonists, minor tranquilizers, antihistamines, and benzodiazepines (except for nighttime sedation);
- Patients with seizure disorders requiring anticonvulsant therapy;
- Those receiving thiazides as chronic antipsychotic medications;
- Those with known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction.
Key Trial Info
Start Date :
August 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT06952920
Start Date
August 21 2025
End Date
June 30 2028
Last Update
December 15 2025
Active Locations (1)
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1
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810000