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NCT Number: NCT03649230

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

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).

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Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tom Baker Cancer Center, Calgary, Alberta, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

300mg netupitant/0.5mg palonosetron hydrochloride

Drug

Antiemetic (NK1 receptor antagonist/5-HT3 receptor antagonist)

Other names: Akynzeo®

Primary outcomes

  1. Total Functional Living Index-Emesis (FLIE) Score at Cycle 1

    Time frame: 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 (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

  1. Complete Response

    Time frame: 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)

  2. Severity of Nausea on Day 5 (Change From Day 1)

    Time frame: 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").

Sponsors and collaborators

Lead sponsor

Purdue Pharma, Canada

Industry

Registry information

Official study 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.

Acronym: EVOLVE_CINV

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 28, 2018
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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