Actively Recruiting

Phase 2
Age: 18Years - 85Years
All Genders
NCT07537660

Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Gemcitabine Plus Paclitaxel

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 gemcitabine combined with paclitaxel protein-bound in pancreatic cancer treatment. 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 gemcitabine plus paclitaxel protein-bound 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 Gemcitabine Plus Paclitaxel

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 85 years
  • Diagnosis of pancreatic cancer after surgery or advanced pancreatic cancer needing chemotherapy with gemcitabine plus paclitaxel albumin-bound
  • ECOG performance status score of 0 to 2
  • Normal blood counts (platelets > 80 x10^9/L; white blood cells > 3 x10^9/L; neutrophils > 1.5 x10^9/L)
  • Serum bilirubin less than or equal to 1.5 times upper limit of normal; transaminase less than or equal to 5 times upper limit of normal
  • No ascites, no gastrointestinal obstruction, normal blood clotting, serum albumin at least 30 g/L
  • Liver function classified as Child-Pugh Grade A
  • Serum creatinine less than upper limit of normal or creatinine clearance greater than 50 ml/min
Not Eligible

You will not qualify if you...

  • Local inflammation or infection of the ear
  • Bleeding tendency or blood clotting disorders
  • Severe ascites
  • Gastrointestinal obstruction
  • Hypertensive crisis or hypertensive encephalopathy
  • Severe uncontrolled infections or diabetes
  • Serious heart diseases including recent stroke, heart attack, poorly controlled hypertension, unstable angina, heart failure (NYHA Class 2-4), or arrhythmias needing treatment
  • History or signs of central nervous system diseases such as brain tumor, uncontrolled epilepsy, brain metastasis, or stroke
  • Allergic reaction to study drugs
  • Pregnant or breastfeeding women
  • Other diseases or impairments from metastasis or physical exam findings that increase risk for complications
  • Unable or unwilling to follow the study protocol

AI-Screening

AI-Powered 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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