Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer

This prospective, multicenter, randomized, double-blind, sham-controlled trial investigates the efficacy of electroacupuncture (EA) combined with standard quadruple antiemetic therapy (olanzapine + dexamethasone + 5-HT3 receptor antagonist + NK-1 receptor antagonist) versus sham EA plus identical antiemetic regimen for chemotherapy-induced gastrointestinal symptom clusters (nausea, vomiting, poor appetite, and xerostomia ). The EA group receives true acupuncture with continuous wave stimulation (2Hz frequency, ≤10mA intensity as tolerated, 30min/session) administered: (1) 1-2h pre-chemotherapy on Day 1, and (2) daily at 9:00-10:00 from Days 2-4. Controls receive sham EA with an identical treatment schedule and the same antiemetics. Assessments during Days 1-5 include: Researchers record the incidence of nausea, vomiting, poor appetite, and xerostomia; Collection of weight, ECOG scores, and EQ-5D-5L questionnaires; documentation of antiemetic/chemotherapy use, concomitant medications, and adverse events; laboratory tests per cycle; and imaging when indicated. Blood samples are preserved every two cycles. Primary/secondary outcomes and adverse events are systematically evaluated.

Inclusion criteria

• Radiologically and 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 criteria

• 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.