A comparative study of Aprepitant and Olanzapine in the prevention of chemotherapy induced nausea and vomiting in carcinoma of breast patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- To Compare the efficacy of Aprepitant and Olanzapine in the prevention of Chemotherapy Induced Nausea.
研究概览
简要总结
ChemotherapyInduced Nausea and Vomiting (CINV) the most common side effect of chemotherapy is associated with a significant deterioration in quality of life and is perceived by patients as a major adverse effect of treatment.
Chemotherapyis a common modality for treatment of Carcinoma Breast. Regardless of the factthat chemotherapy improves survival, it has its own toxicity and side effectsof which nausea and vomiting being significant can affect patient compliance.To avoid the clinical sequelae of CINV like dehydration, electrolyte imbalance,malnutrition, anorexia, stress and anxiety, it is imperative to provideprophylaxis and treatment for CINV.
The principalneurotransmitters that drive CINV in all forms are serotonin, dopamine,acetylcholine, and substance P. The use of 5-hydroxytryptamine3(5-HT3) receptor antagonist plus dexamethasone has significantly improvedthe control of acute CINV. Recent studies have demonstratedadditional improvement in the control of acute CINV and delayed CINV with theuse of newer agents: Palonosetron, a second generation 5-HT3 receptorantagonist. Aprepitant, the first agent available in the drugclass of neurokinin-1 (NK1)-receptor antagonists andOlanzapine, an antipsychotic which is used in the treatment of psychoticsymptom, blocks multiple neurotransmitters in the central nervoussystem. These newer drugs incorporated in prophylactic regimensfor CINV have resulted in significantly reduced rates of this feared complicationof cytotoxic chemotherapy. A recent randomized trial evidence has suggestedthat Olanzapine may have a role in both the prevention and treatment of CINV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)(—)
- 性别
- Female
入选标准
- •Histologically confirmed breast cancer.
- •Chemotherapy naive patients.
- •Not complaining of nausea in the past 24 hours prior to initiation of chemotherapy.
- •Renal and liver function tests of the patients within the normal range
- •Patients with child bearing potential had to have a negative urine pregnancy test.
排除标准
- •History of seizure disorder
- •Brain Metastasis
- •Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone for 30 days prior to or during protocol therapy.
- •Hypersensitivity to olanzapine
- •History of cardiac arrhythmia
- •Uncontrolled congestive cardiac failure or acute myocardial infarction in the previous 6 months
- •History of diabetes mellitus.
结局指标
主要结局
To Compare the efficacy of Aprepitant and Olanzapine in the prevention of Chemotherapy Induced Nausea.
时间窗: Day 1 to day 5 from the start of chemotherapy
次要结局
- To Compare the efficacy of Aprepitant and Olanzapine in the prevention of acute and delayed emesis(Day 1 to day 5 from the start of chemotherapy)
