Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Trastuzumab Deruxtecan
Recruiting · NCT07537673 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 trastuzumab deruxtecan in breast cancer palliative therapy. 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 trastuzumab deruxtecan? 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 trastuzumab deruxtecan treatment. Starting from the day of trastuzumab deruxtecan treatment (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.
Who can take part
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 is running
1 location listed.
- Second Affiliated Hospital of Zhejiang University School of Medicine - Hangzhou, China