CTRI/2024/07/071163尚未招募2 期
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 - Pi
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
研究者
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