A Phase III Randomized open label Non Inferiority study to Evaluate the efficacy of Oral Ondansetron and Dexamethasone vs Intravenous Ondansetron and Dexamethasone in prevention of chemotherapy induced nausea and vomiting in patients receiving highly emetogenic chemotherapy HEC
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- The proportion of patients who achieve complete response in chemotherapy induced nausea and vomiting during the overall phase means 0 to 120 hours of receiving Highly emetogenic chemotherapy
研究概览
简要总结
Although guidelines recommend the use of both oral as well as intravenous antiemetics no head to head trials are available to compare efficacy of oral vs intravenous ondansetron and dexamethasone combination for prevention of CINV in treatment naïve newly diagnosed cancer patients As oral ondansetron and dexamethasone have ease ofadministration in comparison to IV and are cost effective with possibility of less side effects
This study intends to generate level 1 evidence for supporting the use of oral ondansetronand dexamethasone in lieu of IV
We will be comparing oral ondansetron and dexamethasone with its Intravenous formulation for prevention of CINV in newly diagnosed cancer patients recieving single day highly emetogenic chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects aged 18 years and above ECOG PS 0 to 2 Treatment naïve newly diagnosed cancer patients Patients who will be receiving single day regimens of HEC containing AC anthracyclines and cyclophosphamide Cisplatin Dacarbazine and Actinomycin D Patient who are willing to sign a written informed consent and participate in the study.
排除标准
- •Vomiting retching or more than mild nausea within 24 hours before the start of chemotherapy Active infection or uncontrolled medical condition other than malignancy Severe cognitive compromise history of central nervous system disease eg cerebral hemorrhage cerebral infarction brain metastases or a seizure disorder Patients having serum creatinine 2mg per dl or more Patients with gastric surgery and small intestinal surgery or gastrointestinal obstruction Patients on Ryles tube or Patients who are unable to swallow Patients scheduled for or receiving radiotherapy Patients having an aspartate or alanine aminotransferase level that was more than 3 times the upper limit of the normal range and total bilirubin concentration of 2 mg per dL or more Patients with cardiac arrhythmia uncontrolled congestive heart failure or acute myocardial infarction within the previous 6 months Patients with history of uncontrolled diabetes mellitus Patients receiving medication that strongly induces CYP3A4 activity eg rifampicin phenytoin carbamazepine phenobarbital Patients with history of using any of the following drugs within 48 h before enrollment opioids aprepitant 5-HT3-RA dexamethasone dopamine receptor antagonists antihistamines benzodiazepines or phenothiazine antipsychotic agents Patients receiving Drugs other than chemotherapeutic agents with the potential to cause emesis Hypersensitivity to study drug: Known prior severe hypersensitivity to investigational product or any component in its formulations Pregnant patient or those with positive pregnancy test done using pregnancy test kit within 7 days before enrolment.
结局指标
主要结局
The proportion of patients who achieve complete response in chemotherapy induced nausea and vomiting during the overall phase means 0 to 120 hours of receiving Highly emetogenic chemotherapy
时间窗: 0 to 120 hours
次要结局
- 1 The proportion of patients who achieve a complete response in CINV during the acute phase 0 to 24 hours(2 The proportion of patients who achieve a complete response in CINV during the delayed phase 25 to 120 hours)
研究者
Dr Gurmeet Kaur
All Institute of medical sciences New Delhi