Clinical trial · Observational
Observational Study on the Use of Akynzeo® in Patients Receiving 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.
NCT03649230CI-TRIAL-00068895EVOLVE_CINVcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-Induced Nausea and Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 300mg netupitant/0.5mg palonosetron hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Total Functional Living Index-Emesis (FLIE) Score at Cycle 1
- timeFrame
- Day 5 of cycle 1
- description
- 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.
Secondary outcomes (2)
- measure
- Complete Response
- timeFrame
- Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days
- description
- No emetic episode and no use of rescue medication in the overall period (0-120h/Day 1-5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Patient scheduled to receive a highly emetogenic chemotherapy (HEC). 2. 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. 3. Age ≥ 18 years. 4. Women of childbearing potential must use effective contraception during therapy and up to one month after treatment with Akynzeo®. 5. 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. 6. 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. 7. Patient is participating in another clinical trial where antiemetic treatment is not pre-specified by the study protocol. Exclusion Criteria: 1. Women of child bearing potential who are pregnant, planning on becoming pregnant or breast feeding. 2. Hypersensitivity to active substances, excipients or other ingredients of Akynzeo®. 3. Concomitant use of pimozide, terfenadine, astemizole, or cisapride. 4. Patient currently enrolled in another clinical trial where antiemetic treatment is pre-specified by the study protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.