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RECRUITING

NCT07716176

PHASE3

Auricular Point Stimulation Plus Dexamethasone Versus Standard Antiemetic Regimen for Nausea and Vomiting Caused by Docetaxel Plus Cyclophosphamide

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

This study aims to evaluate whether the preventive and suppressive effects of auricular point stimulation combined with dexamethasone on nausea and vomiting induced by the docetaxel plus cyclophosphamide regimen are non-inferior to the standard antiemetic regimen. Additionally, it will assess patients' appetite, gastrointestinal function, and other related indicators, and explore the significant role of integrated traditional Chinese medicine and Western medicine interventions in improving patients' quality of life during chemotherapy, thereby providing a clinical reference for optimizing the management of adverse reactions of this chemotherapy regimen. The main questions it aims to answer are: Whether the preventive and suppressive effects of auricular point stimulation combined with dexamethasone on nausea and vomiting induced by the docetaxel plus cyclophosphamide regimen are non-inferior to the standard antiemetic regimen? In comparison with a standard pharmacologic antiemetic regimen, does auricular point stimulation plus dexamethasone effectively reduce the incidence of appetite loss, weakened or disordered gastrointestinal function, and other uncomfortable conditions? Breast cancer patients receiving adjuvant chemotherapy with the docetaxel plus cyclophosphamide regimen after surgery will be randomly assigned in a 1:1 ratio to either the auricular point stimulation group or the standard pharmacologic antiemetic regimen group. Patients in the auricular point stimulation group 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. Patients in the standard pharmacologic antiemetic regimen group will: Receive the standard pharmacologic antiemetic regimen chosen by their physicians according to clinical guidelines.

Official title: Auricular Point Stimulation Plus Dexamethasone Versus Standard Antiemetic Regimen for Nausea and Vomiting Caused by Docetaxel Combined With Cyclophosphamide in Breast Cancer Adjuvant Chemotherapy

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-12

Completion Date

2026-12-12

Last Updated

2026-07-21

Healthy Volunteers

Conditions

Nausea and Vomiting Caused by Chemotherapy

Interventions

DRUG

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, at noon, and in the 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.

DRUG

Standard pharmacologic antiemetic regimen

Receive the standard pharmacologic antiemetic regimen chosen by their physicians according to clinical guidelines and patients' actual conditions, including dexamethasone ± 5-HT3 receptor inhibitor ± NK1 receptor inhibitor ± Olanzapine.

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.

Locations (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China