Efficacy and safety of Pyridoxine as add-on therapy in prevention of chemotherapy induced nausea and vomiting in patients of Cancer Breast receiving Epirubicin and Cyclophosphamide (PiN study):A Phase II, single arm study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- To assess the no nausea proporation among patients with breast cancer receiving EC chemotherapy when receiving anti-emetic prophylaxis with the combination of standard 4-drug ondansetron, aprepitant, dexamethasone, and olanzapine with add on pyridoxine
研究概览
简要总结
Extent of the problem: Chemotherapy induced nausea and vomiting (CINV) is a common, predictable and preventable acute side effect of chemotherapy and it negatively affects the overall experience of chemotherapy. Recent guidelines recommend four drug regimen of Olanzapine, NK1 receptor antagonist, 5HT3 antagonist and dexamethasone as current standard for preventing chemotherapy induced nausea and vomiting. Despite adherence to standard treatment regimens, some patients continue to experience episodes of nausea and vomiting both in acute and delayed phase. Nausea can have significant negative impact on quality of life of patients. Hence there is a need for improving currently available regimens for CINV prophylaxis.Since pyridoxine is a fairly safe agent and is planned for short term use (4 days per cycle), it is expected to be safe when combined with current anti emetic prophylactic agents. Till date, there is no data on any combination which is superior to the 4-drug regimen for anti CINV prophylaxis. Also, there is limited data on the use of pyridoxine as anti-nausea agent in patients receiving chemotherapy (despite extensive data in hyperemesis gravidarum).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients receiving first-line therapy with Receiving Anthracycline or Cyclophosphamide combination Patients must provide written informed consent including consent for tele-phonic conversation or questionnaire both in the current and next cycle of chemotherapy.
- •ECOG Eastern Cooperative Oncology Group performance status of 0, 1, and 2 at the time of enrolment in the study Adequate blood counts and organ functions ANC more than 1500/cumm Total Bilirubin less than or equal to 1.5 times ULN AST (SGOT) less than or equal to 3times ULN ALT (SGPT) less than or equal to 3times ULN Serum creatinine less than or equal to 2 mg/dL or a measured creatinine clearance morethan or equal to 40 mL/min according to Cockcroft-Gault formula.
排除标准
- •Nausea or vomiting in the past 24 hours.
- •Severe neurocognitive impairment.
- •Known history of central nervous system organic disorder Known psychiatric disorder Human Immunodeficiency Virus infectio and or on anti-retroviral therapy and or HCV infection patients who are anti-HCV positive but have been treated and have undetectable viral load would be permitted to be part of the study.
- •Active Hepatitis B infection in patients who are Hepatitis B carriers, the markers of active infection such as HBeAg and HBV DNA titers must be negative, and patients would be continued on appropriate prophylaxis with antivirals throughout the study.
- •Regular alcohol intake 3 or more drinks equivalent of 45 ml of liquor per week Known hypersensitivity to the study agents Known cardiac arrhythmia, uncontrolled CHF, or acute MI within the last 6 months History of uncontrolled DM.
结局指标
主要结局
To assess the no nausea proporation among patients with breast cancer receiving EC chemotherapy when receiving anti-emetic prophylaxis with the combination of standard 4-drug ondansetron, aprepitant, dexamethasone, and olanzapine with add on pyridoxine
时间窗: From the 0 to 120 hours of 2nd chemotherapy cycle
次要结局
- Complete response no emetic episode and no use of rescue medications in acute, delayed and overall period(No nausea in acute period 0-24hours)
研究者
Prasanth Ganesan
Jawaharlal Institute of Postgraduate Medical Education and Research