Ear acupressure plus dexamethasone to prevent chemo nausea from docetaxel and cyclophosphamide

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 Phase 2 interventional study gives participants auricular acupressure (bean seeds applied to specific points on one ear) together with an intravenous dose of dexamethasone as a preventive antiemetic when they receive docetaxel plus cyclophosphamide for adjuvant breast cancer chemotherapy. The study will monitor rates and severity of chemotherapy-induced nausea and vomiting (CINV) in the days around each chemotherapy administration and record gastrointestinal symptoms such as appetite loss, constipation, and diarrhea. Safety assessments will include local auricle reactions and overall effects on gastrointestinal function and laboratory tests. The goal is to see if adding auricular stimulation allows effective CINV control with fewer or lower-intensity antiemetic medications and better patient comfort.

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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

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  Recruiting Phase 3 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou · NCT07716176

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  Recruiting Phase 4 The First Hospital of Jilin University · Changchun, Jilin · NCT07908888

• Chemotherapy sensitivity-guided Culmerciclib combo for HR+/HER2- breast cancer before surgery

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  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07900516

• Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL

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• Can older adults with breast cancer tolerate a dense CMF chemo schedule

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  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07768436

• Lower Dose Cyclophosphamide After Haploidentical Stem Cell Transplant

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  Recruiting Phase 2 Tata Memorial Centre · Navi Mumbai, Maharashtra and 1 other locations · NCT07719946

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.