Electroacupuncture to reduce chemo-related nausea and other gut symptoms in breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, double-blind, sham-controlled multicenter trial comparing electroacupuncture plus standard quadruple antiemetic therapy to sham electroacupuncture with the same antiemetic regimen in early-stage breast cancer patients. True electroacupuncture is delivered once 1–2 hours before chemotherapy on Day 1 and daily on Days 2–4 for 30 minutes per session with low-frequency electrical stimulation, while controls receive a matched sham procedure. Daily assessments during Days 1–5 record incidence and severity of nausea, vomiting, poor appetite, and xerostomia, along with weight, ECOG, EQ-5D-5L, medication use, adverse events, laboratory tests, and periodic blood sampling for multi-omics and genomic analyses. Randomization and blinded sham control are designed to isolate the specific effect of electroacupuncture and to link clinical effects with biological mechanisms.

Why it matters

Who can join: the full rules

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.

Where it's running

• Qinghai University Affiliated Hospital
  Xining, Qinghai, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.