A Phase IV, Real World Observational Study On The Use Of Akynzeo® (Netupitant/Palonosetron) For The Prevention Of Nausea and Vomiting in Oncology Patients Receiving Highly Emetogenic Chemotherapy (HEC) Over Multiple Cycles.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 17
- 主要终点
- Total Functional Living Index-Emesis (FLIE) Score at Cycle 1
研究概览
简要总结
This Canadian, multi-centre, prospective, observational real-world study is designed to collect patient-reported outcome data on the use of Akynzeo® (netupitant/palonosetron) for the prevention of nausea and vomiting in oncology patients receiving highly emetogenic chemotherapy (HEC).
详细描述
The study will assess quality of life using the Functional Living Index of Emesis (FLIE) questionnaire and generate Real World Evidence in support of existing clinical trial data, including effectiveness and safety of Akynzeo® in the real world setting for the prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •Patient scheduled to receive a highly emetogenic chemotherapy (HEC).
- •Patient scheduled to receive antiemetic prevention with Akynzeo® according to the approved Canadian Product Monograph as deemed medically necessary by the participating physician independently from this study.
- •Age ≥ 18 years.
- •Women of childbearing potential must use effective contraception during therapy and up to one month after treatment with Akynzeo®.
- •Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent prior to or at the screening visit.
- •Patient is able and willing to comply with the study protocol for the entire length of the study and will follow all study requirements, procedures and complete all visits as required.
- •Patient is participating in another clinical trial where antiemetic treatment is not pre-specified by the study protocol.
排除标准
- •Women of child bearing potential who are pregnant, planning on becoming pregnant or breast feeding.
- •Hypersensitivity to active substances, excipients or other ingredients of Akynzeo®.
- •Concomitant use of pimozide, terfenadine, astemizole, or cisapride.
- •Patient currently enrolled in another clinical trial where antiemetic treatment is pre-specified by the study protocol.
结局指标
主要结局
Total Functional Living Index-Emesis (FLIE) Score at Cycle 1
时间窗: Day 5 of cycle 1
The Functional Living Index - Emesis questionnaire is a validated patient reported outcome with the objective of assessing the impact of chemotherapy-induced nausea and vomiting on patient's daily function. Questionnaire consists of a nausea domain and a vomiting domain of nine items each where the patient should rate how much nausea and vomiting have affected the quality of life. For each question the patient will rate how much nausea (or vomiting) has affected an aspect of his quality of life during the past five days. Each question uses a visual analogue scale (100 mm) and an ordinal scale (where 1= no emesis-7=a great deal). The minimum total score is 18 and the maximum total score is 126. Higher scores indicate less impairment on daily life as a result of nausea or vomiting. A FLIE total score \> 108 indicates no impairment on daily life as a result of nausea or vomiting. Assessed by patient following day 5 of each cycle.
次要结局
- Severity of Nausea on Day 5 (Change From Day 1)(Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days)
- Complete Response(Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days)