Ear acupressure plus dexamethasone to prevent nausea and vomiting during gemcitabine and albumin‑bound paclitaxel treatment for pancreatic cancer

Auricular Point Stimulation Plus Dexamethasone for Nausea and Vomiting Caused by Gemcitabine Combined With Paclitaxel Protein-bound in Pancreatic Cancer Treatment

This will see if ear acupressure with bean seeds plus an IV dose of dexamethasone can prevent nausea and vomiting in people with pancreatic cancer receiving gemcitabine combined with albumin‑bound paclitaxel.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou)
• Trial ID: NCT07537660 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study combines auricular point stimulation (acupressure with bean seeds on specific ear points) with an intravenous dose of dexamethasone given as a preventive antiemetic around cycles of gemcitabine plus albumin‑bound paclitaxel. Participants receive auricular acupressure on one ear in addition to standard dexamethasone and are followed for incidence and severity of nausea and vomiting, appetite changes, gastrointestinal function, and safety. The study also monitors whether this approach reduces the need for multiple antiemetics and lessens drug‑related GI side effects such as constipation, bloating, or diarrhea. Eligible patients are adults with resected or advanced pancreatic cancer who meet performance status and laboratory criteria, while those with local ear infection or bleeding/coagulation problems are excluded.

Who should consider this trial

Good fit: Adults aged 18–85 with resected or advanced pancreatic cancer scheduled for gemcitabine plus albumin‑bound paclitaxel, with ECOG 0–2 and adequate blood, liver, and kidney function, are ideal candidates.

Not a fit: Patients with local ear inflammation or infection, bleeding or coagulation disorders, significant hepatic or renal impairment, or those not receiving the specified chemotherapy regimen are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could reduce chemotherapy‑related nausea and vomiting and decrease reliance on multiple antiemetic drugs, helping preserve gastrointestinal function and improve quality of life.

How similar studies have performed: Some prior studies of auricular acupuncture or acupressure have shown modest benefit for chemotherapy‑related nausea, but combining auricular stimulation with dexamethasone for this specific regimen is relatively novel and not yet well established.

Eligibility criteria

Inclusion Criteria: Patients must meet the following inclusion criteria for the study:

* 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 Criteria: Patients who meet any of the following criteria will be excluded from the study:

* 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.

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 Chemotherapy