Actively Recruiting

Phase 2
Age: 18Years - 85Years
All Genders
NCT07537699

Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Docetaxel Plus Cyclophosphamide

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 docetaxel combined with cyclophosphamide in breast cancer adjuvant chemotherapy. 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 the docetaxel plus cyclophosphamide regimen? 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 chemotherapy. Starting from the day of chemotherapy (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 Docetaxel Plus Cyclophosphamide

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years to 85 years
  • Have undergone radical mastectomy and require postoperative chemotherapy with docetaxel combined with cyclophosphamide
  • ECOG performance status score of 0-2
  • 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, transaminase ≤ 5 times upper limit of normal
  • No ascites, no gastrointestinal obstruction, normal coagulation function, serum albumin ≥ 30 g/L
  • Child-Pugh liver function classification Grade A
  • Serum creatinine below upper limit of normal or creatinine clearance rate > 50 ml/min
Not Eligible

You will not qualify if you...

  • 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 recent stroke or heart attack, uncontrolled hypertension, unstable angina, congestive heart failure (NYHA Class 2-4), and cardiac arrhythmias requiring treatment
  • History or evidence of central nervous system diseases such as brain tumor, epilepsy, brain metastasis, or stroke
  • Hypersensitivity to any study drugs
  • Pregnant or lactating women
  • Other diseases or impairments suggesting contraindications or high risk for treatment complications
  • Unable or unwilling to comply with the study protocol

AI-Screening

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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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