NCT03649230

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 207 (actual)
• Sponsor: Purdue Pharma, Canada · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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).

Conditions

• Chemotherapy-Induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	300mg netupitant/0.5mg palonosetron hydrochloride	Antiemetic (NK1 receptor antagonist/5-HT3 receptor antagonist)

Timeline

• Start date: 2018-10-03
• Primary completion: 2019-12-30
• Completion: 2020-01-30
• First posted: 2018-08-28
• Last updated: 2023-08-18
• Results posted: 2023-08-18

Locations

17 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study