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Clinical Trials/NCT07537660
NCT07537660
Recruiting
Phase 2

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 University1 site in 1 country25 target enrollmentStarted: November 25, 2025Last updated:

Overview

Phase
Phase 2
Status
Recruiting
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
25
Locations
1
Primary Endpoint
Proportion of patients experiencing nausea as assessed by NIC-CTC AE4.0

Overview

Brief 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.

Detailed Description

Gemcitabine combined with paclitaxel protein-bound is currently one of the commonly used chemotherapy regimens for postoperative adjuvant and palliative treatment of pancreatic cancer. While it improves patient survival rates, it is also associated with certain gastrointestinal adverse reactions. Chemotherapy-related nausea and vomiting are relatively common, with an incidence of approximately 10%. The majority of these symptoms occur on the day of administration and within the following four days. This regimen is currently classified as a low emetic risk treatment in clinical guidelines. The recommended prophylactic antiemetic strategy typically involves corticosteroids (e.g., dexamethasone) and/or 5-HT3 receptor antagonists (e.g., ondansetron, palonosetron). In clinical practice, single-agent antiemetic therapy often fails to effectively prevent delayed nausea and vomiting. Consequently, most physicians opt for dual-agent antiemetic therapy. However, excessive use of antiemetics frequently leads to drug-related gastrointestinal adverse reactions such as anorexia, bloating, constipation, and diarrhea. Studies have shown that the incidence of constipation in chemotherapy patients treated with palonosetron nearly doubles. The intensive use of antiemetics severely impacts patients' gastrointestinal function, quality of life, and even their treatment adherence. Therefore, how to effectively prevent chemotherapy-induced nausea and vomiting while minimizing the side effects of antiemetic therapy itself has become a practical issue that healthcare professionals urgently need to address.

Auricular point pressotherapy is a traditional Chinese medicine (TCM) external therapy. It involves accurately pasting Vaccaria seeds on corresponding auricular points with adhesive tapes and stimulating the points through moderate pressing to regulate physical functions and treat diseases. According to TCM theory, the ear is closely connected to the internal organs and meridians of the human body, and all twelve meridians are directly or indirectly linked to the ear. Auricular point pressotherapy can unblock meridians and balance yin and yang by stimulating corresponding auricular points, thereby alleviating CINV and other adverse reactions. It is an economical, non-invasive, and low-side-effect natural therapy. Meanwhile, auricular point pressotherapy can effectively improve gastrointestinal function, thus significantly reducing gastrointestinal dysfunction caused by chemotherapy and antiemetic drugs, such as anorexia, abdominal distension, constipation, and diarrhea.

Our team summarized the relevant data of patients who voluntarily received auricular point pressotherapy for antiemesis previously. The results showed that among pancreatic cancer patients who received gemcitabine combined with paclitaxel protein-bound for postoperative adjuvant or palliative therapy, 100% of those treated with auricular point pressotherapy plus dexamethasone did not experience grade 2 or above (including grade 2) nausea and had no vomiting on the day of medication and within 3 days thereafter.

Based on the above theoretical and practical basis, this study intends to evaluate the efficacy and safety of auricular point pressotherapy combined with dexamethasone for CINV induced by gemcitabine combined with paclitaxel protein-bound in pancreatic cancer treatment. At the same time, it will assess related indicators such as patients' appetite and gastrointestinal function, and explore the important role of integrated traditional Chinese and Western medicine intervention in improving patients' quality of life during chemotherapy, to provide clinical reference for optimizing the management of adverse reactions of this chemotherapy regimen.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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;

Arms & Interventions

Auricular point stimulation plus dexamethasone group

Experimental

For pancreatic cancer patients who will receive gemcitabine combined with paclitaxel protein-bound for postoperative adjuvant chemotherapy or palliative treatment, preventive antiemetic treatment consisting of unilateral auricular point stimulation at specific acupoints and dexamethasone will be administered within 30 minutes before chemotherapy. Auricular acupoint stimulation is performed by adhering Vaccaria seeds to specific points with adhesive tape and applying moderate pressure until a certain level of soreness is elicited. Vaccaria seeds are kept on the ear from the day of chemotherapy (Day 1) until the end of Day 5.

Intervention: Auricular point stimulation plus dexamethasone (Other)

Outcomes

Primary Outcomes

Proportion of patients experiencing nausea as assessed by NIC-CTC AE4.0

Time Frame: from the day of chemotherapy (Day 1) until the end of Day 5

Participants will be asked to fill out a questionnaire to record whether nausea occurs. If nausea occurs, its grade according to the NIC-CTC AE4.0 should be recorded.

Secondary Outcomes

  • Proportion of patients experiencing vomiting as assessed by NIC-CTC AE4.0(from the day of chemotherapy (Day 1) until the end of Day 5)
  • Proportion of patients requiring additional antiemetics(from the day of chemotherapy (Day 1) until Day 5)

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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