Clinical trial · Interventional
Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Trastuzumab Deruxtecan
Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Trastuzumab Deruxtecan in Breast Cancer Palliative Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nausea and Vomiting Caused by Trastuzumab Deruxtecan | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Auricular point stimulation plus dexamethasone | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Auricular point stimulation plus dexamethasone group
- description
- For breast cancer patients who will receive trastuzumab deruxtecan for breast cancer palliative therapy, preventive antiemetic treatment consisting of unilateral auricular point stimulation at specific acupoints and dexamethasone will be administered within 30 minutes before chemotherapy. Auricular acupoint stimulation is performed by adhering Vaccaria seeds to specific points with adhesive tape and applying moderate pressure until a certain level of soreness is elicited. Vaccaria seeds are kept on the ear from the day of trastuzumab deruxtecan treatment (Day 1) until the end of Day 5.
- interventionNames
- Other: Auricular point stimulation plus dexamethasone
Primary outcomes (1)
- measure
- Proportion of patients experiencing nausea as assessed by NIC-CTC AE4.0
- timeFrame
- from the day of trastuzumab deruxtecan treatment (Day 1) until the end of Day 5
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDStankowicz M, Mauro L, Harnden K, Pennisi A. Management of Chemotherapy-Induced Nausea and Vomiting with Trastuzumab Deruxtecan: A Case Series. Breast Care (Basel). 2021 Aug;16(4):408-411. doi: 10.1159/000511049. Epub 2020 Oct 23. PMID 34602948