Actively Recruiting

Phase 2
Age: 18Years - 85Years
All Genders
NCT07537673

Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Trastuzumab Deruxtecan

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-17

25

Participants Needed

1

Research Sites

48 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Trastuzumab Deruxtecan

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 85 years
  • Breast cancer patients scheduled for palliative treatment with trastuzumab deruxtecan
  • ECOG performance status score of 0 to 2
  • Normal blood counts: platelet count > 80×10⁹/L, white blood cell count > 3×10⁹/L, neutrophil count > 1.5×10⁹/L
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN), and transaminase ≤ 5 times ULN
  • No ascites, no gastrointestinal obstruction, normal coagulation, serum albumin ≥ 30 g/L
  • Liver function Child-Pugh Grade A
  • Serum creatinine below ULN or creatinine clearance rate > 50 ml/min
Not Eligible

You will not qualify if you...

  • Local inflammation or infection of the ear (auricle)
  • Bleeding tendency or blood clotting disorders
  • Severe ascites
  • Gastrointestinal obstruction
  • Hypertensive crisis or hypertensive encephalopathy
  • Severe uncontrolled infections or diabetes mellitus
  • Serious cardiovascular diseases including recent cerebrovascular accident or myocardial infarction within 6 months, uncontrolled hypertension, unstable angina, congestive heart failure (NYHA class 2-4), or arrhythmias requiring medication
  • History or signs of central nervous system diseases such as brain tumor, uncontrolled epilepsy, brain metastasis, or stroke
  • Allergy to any study drugs
  • Pregnant or lactating women
  • Other diseases or metastatic complications contraindicating study drugs or increasing risk
  • Inability or unwillingness to follow study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Actively Recruiting

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Research Team

J

Juan Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Trastuzumab Deruxtecan | DecenTrialz