CTRI/2025/10/096354尚未招募3 期
Pyridoxine in Prevention of Nausea in Patients on Highly Emetogenic Chemotherapy: A Phase III, Randomized, Double-blind, Placebo-controlled Trial (PiN-II Trial)
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER1 个研究点 分布在 1 个国家目标入组 372 人开始时间: 2025年11月3日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- “no nausea” rates in the overall period (0-120 hours)
研究概览
简要总结
This is a randomised double blind study to be conducted among adult patients with cancer planned to start the first cycle of chemotherapy with high risk of vomiting and nausea. The study will compare the control of nausea in the overall period (from 0-120 hours) between arm A and arm B. In arm A patients will receive standard 4 drug anti emetic prophyalxis with pyridoxine 40 mg BD for 4 days. In arm B, patients will receive standard 4 drug anti emetic prophylaxis wtih placebo for 4 days. The standard 4 drug regimen will consist of olanzapine, neurokinin blocker, 5 ht 3 antagonist, and dexamethasone. The secondary end points will be control of emesis, adherence, and quality of life and adverse events. The study will be conducted in India over 6 centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age is greater than or equal to 18 years.
- •2.Diagnosed with malignancy of any stage.
- •3.Planned to receive the first cycle of highly emetogenic chemotherapy.
- •4.Chemotherapy regimens must be highly emetogenic drugs on Day 1 of the cycle and have no chemotherapy on Days 2 through
- •5.Patients must be planned for standard anti-emetic prophylaxis with a four-drug combination.
- •6.ECOG performance status of 0 to 2 at the time of enrolment.
- •7.Negative serum or urine pregnancy test in women of childbearing potential.
- •8.Adequate blood counts and organ functions (within 4 weeks of chemotherapy administration).
- •This includes: Hemoglobin greater than or equal to 7 g/dL.
- •WBC counts: greater than or equal to 4000 per cmm or Absolute neutrophil count greater than or equal to 1500 per cmm.
- •Total Bilirubin less than or equal to 2 times ULN.
- •AST (SGOT) less than or equal to 3 times ULN.
- •Serum creatinine less than or equal to 2 mg/dL.
排除标准
- •1.Prior radiation and/or chemotherapy for current cancer diagnosis or any other cancer in the past.
- •2.Use of a dose of steroid other than dexamethasone.
- •3.Use of a dose of dexamethasone which is higher than what is planned in this study.
- •4.Chronic alcoholism, as determined by the investigator.
- •5.Organ dysfunction which prevents safe delivery of medications.
- •6.Concurrent use of radiation is planned (unless planned to be started greater than or equal to 1 week after cycle 1 day 1).
- •7.Refusal of consent.
- •8.Unable to answer phone calls or cooperate with other study-related activities.
- •9.Use of psychotherapy and/or sedative medications that can interact with the antiemetic agents.
- •10.Serious intercurrent illness or medical condition such as active uncontrolled infection, uncontrolled diabetes, or significant cardiac dysfunction.
- •11.Known history of brain metastatic disease or seizure disorders.
- •12.Use of concurrent quinolone antibiotics or amifostine.
- •13.Human Immunodeficiency Virus (HIV) infection and/or Anti-retroviral therapy and/or Hepatitis C Virus (HCV) infection (unless treated with an undetectable viral load).
- •14.Active Hepatitis B infection.
- •15.Patients with baseline nausea and vomiting due to underlying disease or any other cause.
结局指标
主要结局
“no nausea” rates in the overall period (0-120 hours)
时间窗: 0-120 hours
次要结局
- No nausea rates in the acute (0-24 hours) & delayed (24-120 hours) periods.
研究者
Prasanth Ganesan
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
研究点 (1)
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