[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"olanzapine-contained-four-drug-antiemetic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:olanzapine-contained-four-drug-antiemetic":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100531466","phase-3-electroacupuncture-for-the-prevention-of-chemotherapy-induced-nausea-and-vomiting-in-patients-with-breast-cancer-100531466",false,"NCT06200168","Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer","A Study on Electroacupuncture Combined With Olanzapine-contained Four-drug Antiemetic Therapy for the Prevention of Highly Emetogenic Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer (ECO Study)","Inclusion Criteria:\n\n1. Aged 18 years or older and aged 75 years or younger, of any nationality;\n2. Eastern Cooperative Oncology Group performance status of 0-2;\n3. Patients with breast cancer, with no restrictions on molecular typing; early-stage patients must not have undergone prior chemotherapy, while advanced-stage patients must be candidates for first-line chemotherapy and have declined neoadjuvant or adjuvant chemotherapy for over 3 months. All patients must receive highly emetogenic chemotherapy (HEC) based on anthracycline chemotherapy with cyclophosphamide (EC or AC) or carboplatin (AUC≥4)\u002Fcisplatin;\n4. Predicted life expectancy of ≥3 months;\n5. Adequate bone marrow, kidney, and liver function;\n6. Adequate contraception if premenopausal women;\n7. Written informed consent by the patient before enrolment.\n\nExclusion Criteria:\n\n1. Patients already submitted to chemotherapy;\n2. Is scheduled to receive any non-HEC on Day 1;\n3. Is scheduled to receive any chemotherapy on days 2-4 after HEC;\n4. Received or is scheduled to receive radiation therapy to the abdomen, pelvis, head and neck within 1 week prior to Day 1 or between Days 1 to 5 in cycle 1;\n5. Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and\u002For vomiting;\n6. Have ongoing emesis or CTCAE grade 2 or greater nausea;\n7. Significant medical or mental conditions;\n8. Any allergies to study drug, antiemetics or dexamethasone;\n9. Significantly abnormal laboratory values (platelets, coagulation indexes, absolute neutrophils, AST, ALT, bilirubin or creatinine);\n10. Patients who are pregnant or breast-feeding;\n11. Inflammatory skin reaction;\n12. Has lymphedema in acupuncture stimulation area;\n13. Patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles;\n14. Received acupuncture treatments for any conditions less than 4 weeks before HEC;\n15. Currently using drugs with antiemetic activity (e.g., 5-HT3 receptor antagonists, corticosteroids (except when used at physiological doses), dopamine receptor antagonists, minor tranquilizers, antihistamines, and benzodiazepines (except for nocturnal sedation));\n16. Patients with concomitant severe diseases or with a predisposition to emesis such as gastrointestinal obstruction, active peptic ulcer, and hypercalcemia and symptomatic brain metastasis;\n17. Has a convulsive disorder requiring anticonvulsant treatment;\n18. Patients administered thioridazine as a chronic antipsychotic medication (patients are allowed to receive prochlorperazine and other phenothiazines as a rescue antiemetic treatment);\n19. Concurrent treatment with quinolone antibiotics;\n20. Has a history of chronic alcoholism (determined by the investigator);\n21. Known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction within the past six months;\n22. Has a history of uncontrolled diabetes (e.g., using insulin or oral hypoglycemic agents).",true,"ALL","18 Years","75 Years",{"count":21,"type":22},370,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This randomized controlled phase III trial aims to evaluate the use of electroacupuncture in combination with olanzapine-containing standard quadruple antiemetic drugs for the treatment of nausea and vomiting induced by highly emetogenic chemotherapy (HEC) in patients with breast cancer. Furthermore, it will analyze the relationship between single nucleotide polymorphism and electroacupuncture treatment for chemotherapy-induced nausea and vomiting.",[28,29,30],"Electroacupuncture","Olanzapine-contained Four-drug Antiemetic","Nausea and Vomiting",[32,33,34,35,36],"electroacupuncture","olanzapine-contained four-drug antiemetic","nausea and Vomiting","breast cancer","chemotherapy","RECRUITING","2025-03-27",{"date":40,"type":41},"2025-04-02","ACTUAL",{"date":43,"type":41},"2024-01-16",{"date":45,"type":22},"2026-12-31",{"name":47,"class":48},"Jiuda Zhao","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":49},"100540289","phase-3-electroacupuncture-plus-antiemetic-therapy-for-chemotherapy-induced-nausea-and-vomiting-in-patients-with-breast-cancer-100540289","NCT06314906","Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer","Combining Electroacupuncture With Antiemetic Therapy for Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer: A Clinical Study","Inclusion Criteria:\n\n1. Patients aged 18 to 75 years, inclusive, from any nationality.\n2. Patients diagnosed with early-stage breast cancer.\n3. Eastern Cooperative Oncology Group performance status ranging from 0 to 2.\n4. All patients must undergo highly emetogenic chemotherapy (HEC).\n5. Adequate organ function.\n6. Adequate contraception required for premenopausal women.\n\nExclusion Criteria:\n\n1. Scheduled to undergo chemotherapy between days 2 to 4 following HEC.\n2. Received or is planned to receive abdominal radiation therapy within 1 week before Day 1 in cycle 1.\n3. Significant medical or psychological conditions.\n4. Presents with symptomatic primary or metastatic central nervous system malignancy causing nausea and\u002For vomiting.\n5. Experiencing ongoing vomiting or nausea of grade 2 or higher according to Common Terminology Criteria for Adverse Events (CTCAE).\n6. Any known allergies to the study drug, antiemetics, or dexamethasone.\n7. Patients who have fear of electroacupuncture stimulation or are allergic to stainless steel needles.\n8. Received acupuncture treatments for any conditions within 8 weeks prior to HEC.",{"count":21,"type":22},[25],"This study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer. The research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy regimens. By investigating the synergistic potential of these modalities, the study seeks to provide insights into optimizing supportive care strategies for patients with breast cancer undergoing intensive chemotherapy treatment.",[28,29,30],[32,33,34,35,36],"2024-03-19",{"date":64,"type":41},"2024-03-21",{"date":66,"type":41},"2024-03-07",{"date":68,"type":22},"2027-03-31",{"name":70,"class":48},"Feixue Song"]