Auricular point stimulation with dexamethasone versus standard antiemetics for nausea from trastuzumab deruxtecan

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

In this phase 3 study, adults with breast cancer receiving trastuzumab deruxtecan are randomized to receive auricular point stimulation plus dexamethasone or the standard antiemetic regimen. The goal is to determine non-inferiority of the combined approach for preventing and controlling treatment-induced nausea and vomiting, with secondary assessments of appetite, GI function, and quality of life. The trial integrates traditional Chinese medicine techniques with conventional therapy to see if this combined approach is feasible and beneficial in palliative care. Potential safety, tolerability, and patient-reported outcomes will be collected to inform antiemetic management during trastuzumab deruxtecan treatment.

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; \* 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.

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.

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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.