Observational Study on the Use of Akynzeo® in Patients Receiving HEC (EVOLVE_CINV)
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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).
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).
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.
Actual Study Start Date :
October 3, 2018
Actual Primary Completion Date :
December 30, 2019
Actual Study Completion Date :
January 30, 2020
Resource links provided by the National Library of Medicine
Total Functional Living Index-Emesis (FLIE) score at cycle 1 [ Time Frame: Day 5 of cycle 1 ]
The Functional Living Index - Emesis questionnaire is a patient reported outcome (PRO) validated tool 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 (where 1= no emesis-7=a great deal).
Assessed by patient following day 5 of each cycle.
Secondary Outcome Measures :
Complete Response [ Time Frame: daily Day 1-5 ]
No emetic episode and no use of rescue medication in the overall period (0-120h/Day 1-5)
Severity of Nausea [ Time Frame: daily day 1-5 ]
Severity of nausea assessed using a Visual Analogue Scale (VAS)
Time to failure [ Time Frame: daily Day 1-5 ]
time to first emetic episode or time to rescue
incidence of treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: daily though to study completion approximately 6 months ]
Assessment of patient reported adverse events throughout the observational period
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This study will enroll adult male or female chemotherapy patients of various cancer types who are scheduled to receive chemotherapy with high emetogenic potential for a maximum of 2 days.
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.
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.