NCT07537660Toboroz2. fázis
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 17.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 25 (tervezett)
- Első benyújtás
- 2025. dec. 14.
- Kezdés
- 2025. nov. 25.
- Elsődleges befejezés
- 2026. nov.
- Fő szponzor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Betegségek
- Hasnyálmirigyrák
- NCT-szám
- NCT07537660
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 25
- 2025. nov. 25. és az elsődleges befejezés (2026. nov.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- 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;
Más betegség
- Local inflammation or infection of the auricleBleeding tendency or coagulation disorders;
- Severe uncontrolled systemic complications such as infection or diabetes mellitus;
- 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;
- 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;
Egyéb
- Severe ascites;
- Gastrointestinal obstruction;
- Hypertensive crisis or hypertensive encephalopathy;
- Pregnant or lactating women;
- Inability or unwillingness to comply with the study protocol.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Kína | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.