CTRI/2018/11/016359招募中2/3 期
Comparison of the efficacy of olanzapine, metoclopramide and domperidonefor the symptom abolishment of chemotherapy induced breakthrough nausea andvomiting, randomized open label clinical study.
Jawaharlal Institute Of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2018年4月16日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- To assess and compare the efficacy of metoclopramide, olanzapine, domperidone in symptom abolishment of chemotherapy induced breakthrough nausea and vomiting
研究概览
简要总结
This trial is being conducted to identify the appropriate drug for chemotherapy induced breakthrough nausea and vomiting. Such trials comparing multiple drugs for controlling breakthrough nausea vomiting have not been done in Indian subcontinent. Presently there is no standard drug for break through emesis in both highly and moderately emetogenic chemotherapy induced breakthrough nausea and vomiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Histologically or cytologically confirmed malignant disease 2.Chemotherapy naïve patients 3.Scheduled to receive intravenous either single or multiday highly emetogenetic chemotherapy regimens or moderately emetogenic chemotherapy regimens.
排除标准
- •1.Patients with nausea in 24 h prior to beginning of chemotherapy 2.serum creatinine of >2.0 mg/dl, serum bilirubin of >2.0 mg/dl, SGOT or SGPT values of >3 times the upper limits of normal 3.Pregnant patients 4.Patients on chemotherapy for leukemia.
- •5.Esophageal and stomach malignancies are excluded from the study.
- •6.Patients on continuous, intermittent or concomitant oral chemotherapy 7.Patients on continuous, intermittent or concomitant oral chemotherapy or on opioid (morphine) treatment for pain control.
- •8.Patients with known hypersensitivity to olanzapine, metoclopramide or domperidone, 9.Patients with cardiac arrhythmia, history of congestive heart failure, or acute myocardial infarction within the previous 6 months.
- •10.Patients with known history of CNS disease (e.g., brain metastases, seizure disorder), or treatment with any antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for 30 days prior to or during protocol therapy.
- •11.Patients with concurrent abdominal radiotherapy.
结局指标
主要结局
To assess and compare the efficacy of metoclopramide, olanzapine, domperidone in symptom abolishment of chemotherapy induced breakthrough nausea and vomiting
时间窗: over 1 year of DM course
次要结局
- To assess and compare QOL before and after onset of breakthrough CINV and use of study medications(over 1 year of DM course)
- To assess the use of second line rescue for treatment of breakthrough emesis(over 1 year of DM course)
- To assess and compare the side effect profile of metoclopramide, olanzapine, domperidone in the treatment of breakthrough vomiting(over 1 year of DM course)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic ChemotherapyHematopoietic/Lymphoid CancerNausea and VomitingUnspecified Adult Solid Tumor, Protocol SpecificNCT02116530Alliance for Clinical Trials in Oncology401
Unknown
2 期
Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer CareNauseaVomitingEnd Stage CancerNCT03679182Khon Kaen University15
招募中
2 期
Comparison of the effectiveness of olanzapine, metoclopramide and domperidone for controlling chemotherapy related nausea and vomitingCTRI/2018/11/016359Jawaharlal Institute Of Postgraduate Medical Education and Research
Unknown
2 期
Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and IIIColorectal CancerNCT01196260State Key Laboratory of Cancer Biology8,000
已完成
3 期
Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or MyelodysplasiaLeukemia, Myelocytic, AcuteNCT00136084St. Jude Children's Research Hospital238