Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Phase 2
Started
2025-11-25
Last updated
2026-04-17
Condition(s) studied
Nausea and Vomiting Caused by Chemotherapy
Investigational drug(s) / intervention(s)
Auricular point stimulation plus dexamethasone
Auricular point stimulation plus dexamethasone: On the day of chemotherapy (Day 1): Within half an hour before chemotherapy, administer auricular acupressure on one ear (stimulating the stomach, cardia, and brainstem acupoints for 5 minutes each) along with an intravenous push of 5 mg dexamethasone.
From the day of chemotherapy (Day 1) to the following five days (Day 1-Day 5): Stimulate each acupoint once in the morning, noon, and evening, for 5 minutes each time. If nausea or vomiting occurs, immediately apply additional stimulation for 5 minutes as a temporary measure. Oral antiemetics should be prepared and may be used temporarily if nausea and vomiting are significant and the patient feels the need.
Study summary
The goal of this clinical trial is to learn if auricular point stimulation plus dexamethasone works to effectively prevent or suppress nausea and vomiting caused by docetaxel combined with cyclophosphamide in breast cancer adjuvant chemotherapy. It will also learn about the safety and influence on gastrointestinal function of auricular point stimulation plus dexamethasone.
The main questions it aims to answer are:
Can auricular point stimulation plus dexamethasone effectively prevent or suppress nausea and vomiting induced by the docetaxel plus cyclophosphamide regimen? Can auricular point stimulation plus dexamethasone effectively reduce the incidence of appetite loss, weakened or disordered gastrointestinal function, and other uncomfortable conditions caused by excessive use of antiemetic drugs?
Participants will:
Receive auricular acupressure with bean seeds on specific points of one ear, plus intravenous injection of dexamethasone as a preventive antiemetic treatment within half an hour before chemotherapy. Starting from the day of chemotherapy (Day 1) to the following five days (Day 1-Day 5), provide regular stimulation at the acupressure points daily by themselves according to the protocol provided in this trial. Record their nausea and vomiting status, appetite, and gastrointestinal function-related symptomatic indicators from Day 1 to Day 5. Oral antiemetics are also prepared. If nausea and vomiting are significant or the patient feels the need, they may be temporarily administered as an adjunct.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Proportion of patients experiencing nausea as assessed by NIC-CTC AE4.0 — from the day of chemotherapy (Day 1) until the end of Day 5 Participants will be asked to fill out a questionnaire to record whether nausea occurs. If nausea occurs, its grade according to the NIC-CTC AE4.0 should be recorded.
Trial sites (1)
Facility
City
Region
Status
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
China
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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