Ear acupressure plus dexamethasone to prevent nausea and vomiting from trastuzumab deruxtecan

Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Trastuzumab Deruxtecan in Breast Cancer Palliative Therapy

This trial will try ear acupressure combined with a standard dose of dexamethasone to prevent or reduce nausea and vomiting in breast cancer patients receiving trastuzumab deruxtecan.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Drugs / interventions: trastuzumab, chemotherapy
• Locations: 1 site (Hangzhou)
• Trial ID: NCT07537673 on ClinicalTrials.gov

What this trial studies

Trastuzumab deruxtecan commonly causes nausea and vomiting, particularly on the day of administration and during the following four days, and is considered high emetic risk. In this phase 2 interventional trial, participants receive auricular acupressure (bean seeds taped to specific points on one ear) plus an intravenous dose of dexamethasone within 30 minutes before trastuzumab deruxtecan. The study will track the incidence and severity of nausea and vomiting, appetite changes, gastrointestinal function (constipation, diarrhea, bloating), and safety over the early post-treatment period. The goal is to determine whether adding auricular point stimulation can reduce emesis or allow lower reliance on high-intensity antiemetic drug regimens.

Who should consider this trial

Good fit: Adults aged 18–85 with breast cancer scheduled for palliative trastuzumab deruxtecan who have ECOG 0–2 and adequate blood counts, liver and kidney function are eligible.

Not a fit: Patients with local ear infection or inflammation, bleeding or coagulation disorders, severe ascites or gastrointestinal obstruction, uncontrolled hypertensive crisis, or significant organ dysfunction are excluded and unlikely to benefit from the auricular intervention.

Why it matters

Potential benefit: If successful, this approach could reduce nausea and vomiting and lessen drug-related gastrointestinal side effects, improving comfort and appetite for patients on trastuzumab deruxtecan.

How similar studies have performed: Prior small trials and acupuncture/auricular stimulation studies have shown some benefit for chemotherapy-related nausea, but evidence is limited and combining ear acupressure specifically with dexamethasone for trastuzumab deruxtecan emesis is a novel approach.

Eligibility criteria

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 this trial is running

Hangzhou

• Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, China (RECRUITING)

Study contacts

• Study coordinator: Juan Wang

Conditions: Nausea and Vomiting Caused by Trastuzumab Deruxtecan