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Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer

This study aims to elucidate the therapeutic efficacy of electroacupuncture in managing chemotherapy-induced gastrointestinal symptom clusters through clinical research. Building upon this foundation, multi-omics analyses will be conducted to investigate the regulatory effects and underlying mechanisms of electroacupuncture on gastrointestinal symptoms. Ultimately, genomic studies will be performed to further clarify the key targets of electroacupuncture intervention, thereby providing high-level evidence-based…

ClinicalTrials.gov IDNCT06952920

PhasePHASE3

Enrollment388

SponsorJiuda Zhao

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Standard Quadruple Antiemetic Therapy, Electroacupuncture, Chemotherapy-induced Gastrointestinal Symptom Cluster

About this study

Interventions

Device: electroacupuncture — The acupuncturist applied needles at four acupoints: Zusanli (ST36), Neiguan (PC6), Hegu (LI4), and Zhaohai (KI6), with insertion depths of approximately 20 mm, 15 mm, 20 mm, and 5 mm respectively. Electrical stimulation was delivered in continuous wave mode at 2 Hz frequency with current intensity ≤10 mA (adjusted according to patient tolerance), administered for 30 minutes per session.
Drug: standard quadruple antiemetic therapy — Olanzapine (2.5 mg orally daily, days 1-4), dexamethasone (10 mg intravenously day 1; 7.5 mg intravenously days 2-3), a 5-HT₃ antagonist (palonosetron 0.25 mg intravenously or 0.5 mg orally, or ondansetron 8 mg intravenously or 8 mg orally twice, or tropisetron 5 mg intravenously, all on day 1), and an NK₁ antagonist (fosaprepitant 150 mg intravenously, or aprepitant 130 mg intravenously, or oral aprepitant 125 mg day 1 then 80 mg days 2-3, or netupitant 300 mg orally day 1).
Device: sham electroacupuncture — The same acupoints as the electroacupuncture group were referenced, but with sham acupuncture (minimal insertion at non-acupoint locations) and sham electrical stimulation, while maintaining the same treatment duration and course as the electroacupuncture group.
Drug: standard quadruple antiemetic therapy — Olanzapine (2.5 mg orally daily, days 1-4), dexamethasone (10 mg intravenously day 1; 7.5 mg intravenously days 2-3), a 5-HT₃ antagonist (palonosetron 0.25 mg intravenously or 0.5 mg orally, or ondansetron 8 mg intravenously or 8 mg orally twice, or tropisetron 5 mg intravenously, all on day 1), and an NK₁ antagonist (fosaprepitant 150 mg intravenously, or aprepitant 130 mg intravenously, or oral aprepitant 125 mg day 1 then 80 mg days 2-3, or netupitant 300 mg orally day 1). All the antiemetic drugs used are the same as those in the true acupuncture group.

Primary outcomes

The incidence of chemotherapy-induced gastrointestinal symptom clusters, including nausea, vomiting, poor appetite, and xerostomia, within 120 hours after chemotherapy. (120 hours)

Eligibility information

Inclusion Criteria: 1. Radiologically and pathologically confirmed stage I-III breast cancer; 2. An Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1; 3. Age between 18 and 75 years; 4. Scheduled to receive highly emetogenic chemotherapy regimens, such as EC (epirubicin + cyclophosphamide) or platinum-based regimens, during the first cycle of neoadjuvant/adjuvant chemotherapy; 5. No prior acupuncture treatment within one month before enrollment; 6. 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: 1. Patients with advanced-stage cancer; 2. Those undergoing concurrent chemoradiotherapy; 3. Individuals with severe impairment of vital organ function who cannot tolerate standard-dose chemotherapy; 4. Patients with contraindications to acupuncture, such as active skin infections; 5. Those with digestive system diseases accompanied by nausea and vomiting symptoms that may interfere with accurate assessment; 6. Patients with a history of xerostomia; 7. Individuals with known allergies to the study drugs; 8. Pregnant or breastfeeding patients; 9. 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); 10. Patients with seizure disorders requiring anticonvulsant therapy; 11. Those receiving thiazides as chronic antipsychotic medications; 12. Those with known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction.

Study locations

Qinghai University Affiliated Hospital, Xining, Qinghai 810000 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.