Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Gemcitabine Plus Paclitaxel
Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Gemcitabine Combined With Paclitaxel Protein-bound in Pancreatic Cancer Treatment
Second Affiliated Hospital, School of Medicine, Zhejiang University
25 participants
Nov 25, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- Age ≥ 18 years and ≤ 85 years;
- Patients with pancreatic cancer after radical resection or with advanced pancreatic cancer, who require further chemotherapy with the gemcitabine plus paclitaxel albumin-bound regimen;
- 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 Criteria11
- Local inflammation or infection of the auricleBleeding 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.
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Interventions
On the day of chemotherapy (Day 1): Within half an hour before chemotherapy, administer auricular acupressure on one ear (stimulating the stomach, cardia, and brainstem acupoints for 5 minutes each) along with an intravenous push of 5 mg dexamethasone. From the day of chemotherapy (Day 1) to the following five days (Day 1-Day 5): Stimulate each acupoint once in the morning, noon, and evening, for 5 minutes each time. If nausea or vomiting occurs, immediately apply additional stimulation for 5 minutes as a temporary measure. Oral antiemetics should be prepared and may be used temporarily if nausea and vomiting are significant and the patient feels the need.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07537660