Observational Study on the Use of Akynzeo® in Patients Receiving HEC
CompletedResults postedLast updated 18 August 2023
What this trial tests
trial testing 300mg netupitant/0.5mg palonosetron hydrochloride in Chemotherapy-Induced Nausea and Vomiting in 207 participants. Completed in 30 January 2020.
18 and older, any sex, with Chemotherapy-Induced Nausea and Vomiting. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Total Functional Living Index-Emesis (FLIE) Score at Cycle 1Primary· 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
Group
Value
95% CI
Treatment
109.2
± 17.7
Complete ResponseSecondary· Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days
No emetic episode and no use of rescue medication in the overall period (0-120h/Day 1-5)
Group
Value
95% CI
Cycle 1
84
Cycle 2
97
Cycle 3
104
Cycle 4
101
Cycle 1
96
Cycle 2
78
Cycle 3
62
Cycle 4
44
Cycle 1
16
Cycle 2
9
Cycle 3
9
Cycle 4
6
Severity of Nausea on Day 5 (Change From Day 1)Secondary· Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days
Question 1 of the daily evaluation of the Patient Diary ("How much nausea did you experience on average during the last 24 hours?"). Data was collected on a visual analogue scale. Scale ranges from 0 mm ("no nausea") to 100 mm ("always severe nausea").
Group
Value
95% CI
Cycle 1
-7.1
± 23.8
Cycle 2
-3.3
± 21.6
Cycle 3
-1.4
± 15.4
Cycle 4
-1.5
± 10.7
Adverse events — posted to ClinicalTrials.gov
Time frame: The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Purdue Pharma, Canada
Last refreshed: 18 August 2023
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