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临床试验/NCT07716228
NCT07716228招募中3 期

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年12月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
74
试验地点
1
主要终点
Proportion of patients experiencing nausea as assessed by NIC-CTC AE4.0

研究概览

简要总结

This study aims to evaluate whether the preventive and suppressive effects of auricular point stimulation combined with dexamethasone on nausea and vomiting induced by the gemcitabine plus paclitaxel protein-bound regimen are non-inferior to the standard antiemetic regimen in pancreatic cancer treatment. Additionally, it will assess patients' appetite, gastrointestinal function, and other related indicators, and explore the significant role of integrated traditional Chinese medicine and Western medicine interventions in improving patients' quality of life during chemotherapy, thereby providing a clinical reference for optimizing the management of adverse reactions of this chemotherapy regimen. The main questions it aims to answer are: Whether the preventive and suppressive effects of auricular point stimulation combined with dexamethasone on nausea and vomiting induced by the gemcitabine plus paclitaxel protein-bound regimen are non-inferior to the standard antiemetic regimen? In comparison with a standard pharmacologic antiemetic regimen, does auricular point stimulation plus dexamethasone effectively reduce the incidence of appetite loss, weakened or disordered gastrointestinal function, and other uncomfortable conditions? Pancreatic cancer patients receiving adjuvant or palliative chemotherapy with the gemcitabine plus paclitaxel protein-bound regimen after surgery will be randomly assigned in a 1:1 ratio to either the auricular point stimulation group or the standard pharmacologic antiemetic regimen group. Patients in the auricular point stimulation group 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. Patients in the standard pharmacologic antiemetic regimen group will: Receive the standard pharmacologic antiemetic regimen chosen by their physicians according to clinical guidelines.

详细描述

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-emetogenic-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 whether the preventive and suppressive effects of auricular point stimulation combined with dexamethasone on the CINV induced by the gemcitabine plus paclitaxel protein-bound regimen are non-inferior to the standard antiemetic regimen. Additionally, it will assess patients' appetite, gastrointestinal function, and other related indicators, and explore the significant role of integrated traditional Chinese medicine and Western medicine interventions in improving patients' quality of life during chemotherapy, thereby providing a clinical reference for optimizing the management of adverse reactions of this chemotherapy regimen.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Auricular point stimulation group

Experimental

For pancreatic cancer patients who will receive gemcitabine plus paclitaxel protein-bound for postoperative adjuvant or palliative chemotherapy, 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.

干预措施: Auricular point stimulation plus dexamethasone (Drug)

Standard pharmacologic antiemetic regimen group

Active Comparator

Patients in the standard pharmacologic antiemetic regimen group will receive the standard pharmacologic antiemetic regimen chosen by their physicians according to clinical guidelines and patients' actual conditions.

干预措施: Standard pharmacologic antiemetic regimen (Drug)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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