CTRI/2021/07/034813已完成2 期
A pilot study to evaluate the feasibility and efficacy of dexamethasone free anti emetic regimen in patients receiving highly emetogenic chemotherapy
CI AIIMS0 个研究点目标入组 101 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
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
- •a. Diagnosis of malignancy
- •b. No prior chemotherapy and radiation therapy (RT)
- •c. Age of ââ?°Â¥ 18 ââ?¬â?? up to 70 years
- •d. ECOG Performance status (0-2)
- •e. Complete hemogram (ANC ââ?°Â¥1000/m3, TLC ââ?°Â¥3000/m3, Platelets ââ?°Â¥ 1,00,000/m3), Creatinine (ââ?°Â¤ 2 mg/dl), SGOT / SGPT (ââ?°Â¤ 3 X ULN, Bilirubin <2.0 mg/dl)
- •f. First cycle of highly emetogenic chemotherapy defined as
- •1. Cisplatin at dose ââ?°Â¥70mg/m2 with or without other agents
- •2. Single agent Anthracycline (Doxorubicin ââ?°Â¥ 60mg/m2, Epirubicin ââ?°Â¥ 90mg/m2)
- •3. AC (Doxorubicin ââ?°Â¥ 60mg/m2, Epirubicin ââ?°Â¥ 90mg/m2 + Cyclophosphamide ââ?°Â¥
- •4. Dacarbazine based therapy (ABVD)
- •g. Willing to give written informed consent for the study participation
- •h. Able to read and write in English or Hindi
排除标准
- •a. Patient receiving concurrent quinolone, amifostine, warfarin, OCP, psychiatric drugs, Benzodiazepines, Anti-convulsant drugs, strong or moderate CYP3A4 inhibitors (diltiazem, Ketoconazole), strong CYP3A4 inducers (rifampicin), pimozide, cisapride, terfenadine, astemizole, CYP1A2 inhibitors (ciprofloxacin, fluvoxamine)
- •b. History of chronic alcoholism
- •c. Hypersensitivity to any of the drugs used in the study {Olanzapine, NK-1 antagonist (Fosaprepitant), 5-HT3 antagonist ââ?¬â?? Ondansetron}
- •d. On systemic steroids, active smoker
- •e. History of any uncontrolled systemic disease including hypertension, thyroid, CNS, renal, CHF and MI in last 6 months and requiring hemodialysis, psychiatric disorder
- •f. Symptomatic Brain metastasis / Carcinomatous Meningitis
- •g. History of nausea and vomiting in 24 hours prior to first dose of chemotherapy
- •i. Use of anti-emetic drugs (5-HT3 Antagonist) in last 48 hours
- •j. Started on opioids in last 48 hours
- •l. Female who are pregnant, lactating
研究者
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