Randomized, Placebo Controlled Study of FOND (Fosaprepitant, Ondansetron, Dexamethasone) Versus FOND+O (FOND Plus Olanzapine) for the Prevention of Chemotherapy Induced Nausea and Vomiting in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Overall Percentage of Patients Who Had a Complete Response
研究概览
简要总结
The objective of this study is to compare the effectiveness of olanzapine added to standard triplet therapy (fosaprepitant, ondansetron, and dexamethasone) versus triplet therapy alone in preventing chemotherapy-induced nausea and vomiting (CINV) in hematology patients receiving highly or moderately emetogenic chemotherapy regimens.
详细描述
Nausea and vomiting remains a common and difficult to manage consequence of chemotherapy despite prophylaxis. These symptoms can often lead to a decreased quality of life, dehydration, and malnutrition. Olanzapine is an atypical antipsychotic that blocks multiple neuronal receptors involved in nausea/vomiting pathways. Olanzapine has been studied for breakthrough chemo-induced nausea and vomiting (CINV) as well as in prophylaxis of highly and moderately emetogenic regimens (HEC and MEC, respectively). However, these studies have focused on patients with solid tumor malignancies and chemotherapy regimens of short duration. To date, no publications have reported outcomes from adding olanzapine to standard triplet therapy, for hematology patients, including those undergoing hematopoietic stem cell transplants and those who receive multi-day HEC and MEC regimens.
This is a blinded, placebo controlled trial randomizing patients to receive olanzapine 10 mg orally on all chemotherapy days plus three additional days post chemotherapy or placebo in addition to standard triplet therapy (ondansetron and dexamethasone on each day of chemotherapy and fosaprepitant 150 mg IV on day one of chemotherapy). Inclusion criteria: age 18 or older, receiving inpatient or outpatient HEC or MEC chemotherapy including those regimens given before stem cell transplantation (ABVD, ICE ± R, 7+3 or 5+2, BEAM, Bu/Cy ± ATG, Bu/Flu ± ATG, FluCy ± ATG, BuMel, FluBuCy, Melphalan). Exclusion criteria: allergy to olanzapine, documented nausea/vomiting ≤24 hours before enrollment, treatment with other antipsychotic agents, or declined informed consent. Patients will be randomized to placebo or olanzapine in a block design stratified by chemotherapy type (transplant conditioning vs. chemotherapy only) and number of days of chemotherapy (single vs. multi-day) by the Investigational Drug Pharmacy services at Augusta University Medical Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Inpatient or outpatient hematology patient receiving one of the following regimens:
- •Chemotherapy for hematologic malignancy:
- •Conditioning therapy for stem cell transplantation:
- •Bu/Cy ± ATG
- •Bu/Flu ± ATG
- •FluCy ± ATG
- •FluCy + TBI
- •Melphalan
- •Etoposide + TBI
- •Cyclophosphamide + TBI
排除标准
- •Allergy to olanzapine
- •Documented nausea or vomiting ≤24 hours prior to enrollment
- •Treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone ≤30 days prior to enrollment or planned during protocol therapy
- •Chronic alcoholism
- •Declined or unable to provide an informed consent
研究组 & 干预措施
Triplet Therapy Plus Placebo
All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive placebo on all chemotherapy days and for three additional days post chemotherapy.
干预措施: Placebo (Drug)
Triplet Therapy Plus Olanzapine
All subjects will receive standard triplet antiemetic therapy which consists of ondansetron and dexamethasone on each day of chemotherapy plus fosaprepitant 150 mg IV once per national guidelines for CINV prophylaxis. In addition to those antiemetics, subjects will receive olanzapine 10mg orally on all chemotherapy days and for three additional days post chemotherapy.
干预措施: Olanzapine (Drug)
结局指标
主要结局
Overall Percentage of Patients Who Had a Complete Response
时间窗: Until study completion; estimated 1.5 years
Overall percentage of patients who had a complete response (CR) defined as no emesis and minimal nausea (\< 25 mm on a 100 mm visual analog scale \[VAS\]) during the overall assessment period (starting day 1 of chemotherapy and continuing for 5 days after discontinuation of chemotherapy) for the first cycle of chemotherapy.
次要结局
- Percent of Patients With no Significant Nausea in Overall Assessment Period(Until study completion; estimated 1.5 years)
- Percent of Patients Achieving Complete Protection in Overall Assessment Phase(Until study completion; estimated 1.5 years)
- Percent of Participants With no Significant Nausea in Acute Phase(Until study completion; estimated 1.5 years)
- Percent of Participants With no Significant Nausea in Delayed Phase(Until study completion; estimated 1.5 years)
- Percent of Patients With no Nausea in Overall Assessment Period(Until study completion; estimated 1.5 years)
- Percent of Patients With Complete Response in Acute Phase(Until study completion; estimated 1.5 years)
- Percent of Patients With Complete Response in Delayed Phase(Until study completion; estimated 1.5 years)
研究者
Amber Clemmons
Pharmacist
Augusta University