CTRI/2021/11/038139尚未招募3 期
The safety of omission of H2 antagonist from pre medication strategy in patients planned to receive conventional paclitaxel infusion: An investigator initiated randomized double blind placebo controlled non inferiority trial
CI AIIMS0 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
- 3 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
- •Adults patients with age between 18 years to 70 years
- •Histopathological diagnosis of cancer
- •Willing to participate and to give written informed consent
- •Planned to receive conventional paclitaxel chemotherapy either as single agent or in combination
- •Paclitaxel naive
- •No known hypersensitivity to partner chemotherapy drug
- •ECOG performance status 0-2
- •Stable baseline vital signs: Afebrile, radial artery blood pressure (90/60 â?? 130/90mm Hg), pulse rate 60 â?? 100 / minutes, respiratory rate 12-18/ minutes, 97.8 °F to 99.1 °F (36.5° C to 37.3° C)
排除标准
- •Past history of hypersensitivity reaction to paclitaxel or cremophor containing drugs (cyclosporine, propofol, diazepam, teniposide, etoposide, Vitamin K) or partner drug or pheniramine or ranitidine
- •On chronic systemic steroids or received any dose in the last week
- •No history of hypersensitivity to partner drug
- •Hb < 8gm/dl, ANC < 1000/m3, creatinine > 2mg/dl, Bilirubin > 5 X ULN, transaminases 10 times or more
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