A Randomized open label Study Comparing the Efficacy of Aprepitant-Olanzapine Versus Netupitant-Palonosetron Therapy for Controlling CINV in Patients Receiving Highly Emetogenic Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Complete Response (CR) to antiemetic therapy, defined as no vomiting and no use of rescue medication during:
研究概览
简要总结
Chemotherapy-induced nausea and vomiting (CINV) is one of the most distressing adverse effects experienced by patients receiving highly emetogenic chemotherapy such as cisplatin. Uncontrolled CINV can result in poor nutritional intake, dehydration, reduced treatment compliance, and diminished quality of life. Effective antiemetic therapy is therefore essential to improve tolerance and treatment outcomes.
Aprepitant combined with Olanzapine and the fixed-dose combination of Netupitant-Palonosetron are both recommended regimens for prevention of CINV; however, their comparative efficacy in patients receiving cisplatin-based chemotherapy remains an area of active research. This randomized open-label study evaluates the effectiveness of these two antiemetic regimens in preventing acute and delayed CINV.
The findings from this study may support optimization of antiemetic strategies, improve patient comfort, and enhance adherence to cancer treatment. Results obtained will be analyzed statistically and shared through scientific publication to contribute to clinical practice improvements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing adult patient giving written informed consent.
- •Normal routine blood investigations.
排除标准
- •Patient not willing to give written informed consent.
- •Pregnant and Lactating females.
- •Patient already on treatment with study drug.
- •Patients with known contraindication or refractoriness to study drugs.
结局指标
主要结局
Complete Response (CR) to antiemetic therapy, defined as no vomiting and no use of rescue medication during:
时间窗: Baseline, 24 hours, and 120 hours after chemotherapy in first cycle.
• Acute phase (0–24 hours) after chemotherapy
时间窗: Baseline, 24 hours, and 120 hours after chemotherapy in first cycle.
• Delayed phase (24–120 hours) after chemotherapy
时间窗: Baseline, 24 hours, and 120 hours after chemotherapy in first cycle.
次要结局
未报告次要终点
研究者
Dr Nidhi Mahlawat
Dr Rajendra Prasad Govt Medical College