CTRI/2021/09/036663已完成2 期
Efficacy of olanzapine based, dexamethasone free anti emetic strategy in chemotherapy naive patients planned to receive oxaliplatin based moderately emetogenic chemotherapy: an open label single arm phase II trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- NCI
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- To determine the rate of complete response (no emesis, no use of rescue medications) during the overall period (0-120 hours) in patients receiving oxaliplatin based moderately emetogenic chemotherapy
研究概览
简要总结
- The CINV control rate for MEC ranges from 60% - 85%. The CINV rate varied substantially between different chemotherapy regimens (carboplatin, oxaliplatin). High CINV control rate with oxaliplatin based chemotherapy with two drug anti-regimen. Olanzapine: Cheap, safe and highly effective drug and increases the rate of completeresponse during the overall period by 20-30%. All these factors favours to evaluate prospectively the efficacy and feasibility of olanzapinebased dexamethasone free anti emetic regimen in patients receiving oxaliplatin basedmoderately emetogenic chemotherapy regimen.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of malignancy No prior chemotherapy and radiation therapy (RT) Age of ≥ 18 – up to 65 years ECOG Performance status (0-2) Complete hemogram (ANC ≥1000/m3, TLC ≥3000/m3, Platelets ≥ 1,00,000/m3), Creatinine (≤ 2 mg/dl), SGOT / SGPT (≤ 3 X ULN, Bilirubin <2.0 mg/dl) First cycle of moderately emetogenic chemotherapy defined as Oxaliplatin at dose ≥80mg/m2 with or without other agents Willing to give written informed consent for the study participation.
排除标准
- •Patient receiving concurrent psychiatric drugs (clozapine, risperidone, quetiapine, phenothiazine etc), CNS depressants (azelastine, bromopride, bromperidol, buprenorphine), anti-Parkinson drugs (dopamine agonist), benzodiazepines, cabergoline, anti-cholinergic (glycopyrrolate, ipratropium, levosulpiride, potassium chloride, potassium citrate etc), metoclopramide, pimozide, quinolone, amifostine Hypersensitivity to any of the drugs used in the study {Olanzapine, 5-HT3 antagonist – Ondansetron} On systemic steroids History of any uncontrolled systemic disease including hypertension, thyroid, CNS, renal, CHF and MI in last 6 months and requiring hemodialysis Symptomatic Brain metastasis / Carcinomatous Meningitis History of nausea and vomiting in 24 hours prior to first dose of chemotherapy Use of anti-emetic drugs (5-HT3 Antagonist) in last 24 hours Started on opioids in last 48 hours Female who is pregnant, or breast-feeding his children Patients with dementia related psychosis or psychiatric disorder No concurrent abdominal radiotherapy.
结局指标
主要结局
To determine the rate of complete response (no emesis, no use of rescue medications) during the overall period (0-120 hours) in patients receiving oxaliplatin based moderately emetogenic chemotherapy
时间窗: To determine the rate of complete response (no emesis, no use of rescue medications) during the overall period (0-120 hours) in patients receiving oxaliplatin based moderately emetogenic chemotherapy
次要结局
- To determine the rate of complete response ((no emesis, no use of rescue medications) during the acute period (0-24 hours), delayed period (24 – 120 hours)(To determine the rate of nausea control assessed by “Edmontonsymptomassessment scale†(ESAS) during the acute period (0-24 hours), delayed period (24 – 120 hours) and overall period (0-120 hours))
研究者
研究点 (2)
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