💬In plain words
What the trial is, and whether it could suit you
This study aims to evaluate whether the preventive and suppressive effects of auricular point stimulation combined with dexamethasone on nausea and vomiting induced by trastuzumab deruxtecan are non-inferior to the standard antiemetic regimen in breast cancer palliative therapy. 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 anti-cancer treatment, thereby providing a clinical reference for optimizing the management of adverse reactions of trastuzumab deruxtecan treatment. 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 trastuzumab deruxtecan ar
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📋 Eligibility rules (as published)
Inclusion Criteria:
* Patients must meet the following inclusion criteria for the study: \* Age ≥ 18 years and ≤ 85 years; \* Breast cancer patients scheduled to undergo palliative treatment with trastuzumab deruxtecan; \* 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.
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