Observational Study on the Use of Akynzeo® in Patients Receiving HEC

Official Title

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.

Summary:

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).

Trial Description

Primary Outcome:

  • Total Functional Living Index-Emesis (FLIE) score at cycle 1
Secondary Outcome:
  • Complete Response
  • Severity of Nausea
  • Time to failure
  • incidence of treatment-Emergent Adverse Events [Safety and Tolerability]
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).

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society