The Efficacy of Steroid-Sparing Anti-Emetic Therapy in Patients Treated With High or Moderate Emetogenic Chemotherapy; Single Center Non-Inferiority Open Label Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Complete response (CR) over 120 hours following chemotherapy
研究概览
简要总结
The purpose of this research is to compare two drugs that are routinely used as standard of care for treating nausea and vomiting caused by chemotherapy. This study aims to see if the drug olanzapine is as good as the steroid drug dexamethasone for preventing nausea and vomiting after chemotherapy. Both drugs are listed as appropriate treatment options in the most recent version of National Comprehensive Cancer Network guidelines on Antiemesis.
详细描述
The study will include patients treated with high emetogenic chemotherapy (HEC) or moderate emetogenic chemotherapy (MEC). Emetogenic means that it may cause nausea and vomiting. Your participation will last for 2 cycles of chemotherapy.
For patients given high emetogenic chemotherapy (HEC):
As standard of care for nausea and vomiting after high emetogenic chemotherapy (HEC), subjects will receive fosaprepitant 150 mg IV once, palonosetron 0.25 mg IV once, dexamethasone 12 mg oral or IV once on day 1.
Patients will be randomly assigned to either the DEX group to receive dexamethasone or to the OLA group to receive olanzapine for the first cycle of chemotherapy.
- DEX group: dexamethasone (Decadron) 8 mg oral daily on days 2-4.
- OLA group: olanzapine (Zyprexa)10 mg oral each night on days 1-4. For the second cycle of chemotherapy, the subject will switch to the other group. For future cycles of chemotherapy, the subject will choose the drug that worked best.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •confirmed cancer diagnosis
- •starting cycle 1 of an FDA approved treatment that is categorized as high-emetogenic (nausea and vomiting inducing) chemotherapy per National Comprehensive Cancer Network® guidelines
- •Eastern Cooperative Oncology Group performance score of 0 or 1
- •appropriate renal function
- •appropriate hepatic function
- •appropriate hematologic function.
排除标准
- •Patients will be excluded if they experience nausea or vomiting up to 24 hours before chemotherapy,
- •currently on a glucocorticoid therapy
- •contraindication to glucocorticoid therapy
- •taking any medication that has antiemetic properties.
- •scheduled or planned to receive radiation within one week of or concurrently with chemotherapy
- •brain metastases.
研究组 & 干预措施
OLA then crossover to DEX
OLA group: olanzapine (Zyprexa) 10 mg oral each night after chemotherapy cycle 1 on days 1-4 after HEC (or days 1-3 after MEC).
DEX group: dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 2 on days 2-4 after HEC (or days 2-3 after MEC)
干预措施: DEX group: Dexamethasone (Drug)
DEX then crossover to OLA
DEX group: dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 1 on days 2-4 after HEC (or days 2-3 after MEC)
OLA group: olanzapine (Zyprexa) 10 mg oral each night after chemotherapy cycle 2 on days 1-4 after HEC (or days 1-3 after MEC).
干预措施: OLA group: Olanzapine (Drug)
DEX then crossover to OLA
DEX group: dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 1 on days 2-4 after HEC (or days 2-3 after MEC)
OLA group: olanzapine (Zyprexa) 10 mg oral each night after chemotherapy cycle 2 on days 1-4 after HEC (or days 1-3 after MEC).
干预措施: DEX group: Dexamethasone (Drug)
OLA then crossover to DEX
OLA group: olanzapine (Zyprexa) 10 mg oral each night after chemotherapy cycle 1 on days 1-4 after HEC (or days 1-3 after MEC).
DEX group: dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 2 on days 2-4 after HEC (or days 2-3 after MEC)
干预措施: OLA group: Olanzapine (Drug)
结局指标
主要结局
Complete response (CR) over 120 hours following chemotherapy
时间窗: 120 hours following chemotherapy
Complete response (CR) over 120 hours following chemotherapy, where CR is the absence of emesis and no use of a rescue antiemetic medication, in the acute phase (\<24 hours following chemotherapy), delayed phase (≥24 hours but ≤120 hours following chemotherapy) and overall (≤ 120 hours following chemotherapy).
Number of Patients With Complete Response (CR) Over 120 Hours Following Chemotherapy
时间窗: 120 hours following chemotherapy
The number of patients with Complete response (CR) over 120 hours following chemotherapy, where CR is the absence of emesis and no use of a rescue antiemetic medication, in the acute phase (\<24 hours following chemotherapy), delayed phase (≥24 hours but ≤120 hours following chemotherapy) and overall (≤ 120 hours following chemotherapy). Chemotherapy cycle length varied depending on the physician's decision, congruent with standard-of-care protocols for each cancer type.
次要结局
- medication side effects(120 hours after chemotherapy)
- Total Control (TC- no emesis, no rescue medication, no nausea)(120 hours following chemotherapy)
- Severity of nausea and vomiting self-reported by patient questionnaire(120 hours after chemotherapy)
- Complete control (CC- no emesis, no rescue medication and no more than minimal nausea)(120 hours following chemotherapy)
- Number of Patients With Complete Control (CC) Over 120 Hours Following Chemotherapy(120 hours following chemotherapy)
- Number of Patients With Total Control (TC) Over 120 Hours Following Chemotherapy(120 hours following chemotherapy)