Auricular Point Stimulation With Dexamethasone vs Standard Anti-nausea Medications for Docetaxel‑Cyclophosphamide Therapy

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 Phase 3 trial comparing an auricular point stimulation plus dexamethasone approach to the usual antiemetic regimen for chemotherapy-induced nausea and vomiting. It includes adults with breast cancer treated with postoperative docetaxel–cyclophosphamide and assesses not only nausea and vomiting but also appetite, GI function, and quality of life. The design is non-inferiority, aiming to see if the alternative approach provides similar protection with potentially fewer GI side effects. Primary safety and efficacy outcomes focus on CINV control, with secondary measures on tolerability and patient-reported experience. Conducted at the Second Affiliated Hospital of Zhejiang University School of Medicine, the trial investigates integrating traditional Chinese medicine techniques with conventional pharmacotherapy to optimize supportive care during chemotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must meet the following inclusion criteria for the study:\* Age ≥ 18 years and ≤ 85 years\* After a radical mastectomy, further postoperative adjuvant chemotherapy with docetaxel combined with cyclophosphamide regimen is required.\* ECOG performance status score of 0-2.\* Normal hematological function (platelet count \> 80×10⁹/L; white blood cell count \> 3×10⁹/L; neutrophil count \> 1.5×10⁹/L).\* Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), and transaminase ≤ 5 times the ULN.\* No ascites, no gastrointestinal obstruction, normal coagulation function, and serum albumin ≥ 30g/L.\* Child-Pugh classification of liver function is Grade A.\* Serum creatinine \< ULN, or calculated creatinine clearance rate \> 50ml/min.

Exclusion Criteria:

* Patients who meet any of the following criteria will be excluded from the study: \* Local inflammation or infection of the auricle\* Bleeding tendency or coagulation disorders\* Severe ascites\* Gastrointestinal obstruction\* Hypertensive crisis or hypertensive encephalopathy\* Severe uncontrolled systemic complications such as infection or diabetes mellitus\* Clinically severe cardiovascular diseases, including cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), hypertension that is not well-controlled despite appropriate medication, unstable angina pectoris, congestive heart failure (NYHA Class 2-4), and cardiac arrhythmias requiring drug treatment\* A history of or physical examination findings indicating central nervous system diseases (e.g., primary brain tumor, epilepsy uncontrolled by standard treatment, any history of brain metastasis or stroke)\* Hypersensitivity to any drugs used in the study\* Pregnant or lactating women\* Presence of any other diseases, functional impairment caused by metastatic lesions, or suspicious disorders identified during physical examination, which suggest contraindications to the study drugs or place the patient at high risk of treatment-related complications\* Inability or unwillingness to comply with the study protocol.

Where it's running

• Second Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, China Recruiting

Study contacts

• Study coordinator: Juan Wang
• Email: wangjuan.happy@hotmail.com
• Phone: 8617816190946

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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.