N/A
Completed N=207
Observational Study on the Use of Akynzeo® in Patients Receiving HEC
Source: ClinicalTrials.gov NCT03649230 ↗Enrolled (actual)
207
Serious AEs
19.8%
Results posted
Aug 2023
Primary outcomePrimary: Total Functional Living Index-Emesis (FLIE) Score at Cycle 1 — 109.2 score on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Functional Living Index-Emesis (FLIE) Score at Cycle 1 |
109.2 | — |
| SECONDARY Complete Response |
84; 97; 104; 101; 96; 78 | — |
| SECONDARY Severity of Nausea on Day 5 (Change From Day 1) |
-7.1; -3.3; -1.4; -1.5 | — |
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03649230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.