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

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.

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).

Study Overview

• Status: Completed
• Conditions: Chemotherapy-Induced Nausea and Vomiting
• Intervention / Treatment: Drug: 300mg netupitant/0.5mg palonosetron hydrochloride

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).

• Study Type: Observational
• Enrollment (Actual): 207

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Tom Baker Cancer Center
  • New Brunswick
    • Moncton, New Brunswick, Canada
      • The Moncton Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • NSHA-QEII Health Sciences Centre
    • Sydney, Nova Scotia, Canada
      • Cape Breton Cancer Centre
  • Ontario
    • Barrie, Ontario, Canada
      • Royal Victoria Regional Health Centre
    • Brampton, Ontario, Canada
      • William Osler Health System
    • Kitchener, Ontario, Canada
      • Grand River Regional Cancer Centre
    • London, Ontario, Canada
      • London Health Sciences Centre
    • Thunder Bay, Ontario, Canada
      • Thunder Bay Regional Health Sciences Centre
    • Toronto, Ontario, Canada
      • St. Michael's Hospital
    • Toronto, Ontario, Canada
      • Sunnybrook Health Sciences Center
    • Windsor, Ontario, Canada
      • Windsor Regional Cancer Centre
  • Quebec
    • Greenfield Park, Quebec, Canada
      • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
    • Lévis, Quebec, Canada
      • CISSS de Chaudière-Appalaches
    • Montréal, Quebec, Canada
      • Segal Cancer Centre-Jewish General Hospital
    • Sherbrooke, Quebec, Canada
      • Centre de recherche du CHUS and Hopital Fleurimont
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada
      • Saskatoon Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will enroll adult male or female chemotherapy patients of various cancer types who are scheduled to receive chemotherapy with high emetogenic potential for a maximum of 2 days.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Functional Living Index-Emesis (FLIE) Score at 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.	Day 5 of cycle 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response	No emetic episode and no use of rescue medication in the overall period (0-120h/Day 1-5)	Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days
Severity of Nausea on Day 5 (Change From Day 1)	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").	Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days

Collaborators and Investigators

• Sponsor: Purdue Pharma, Canada
• Investigators: Study Director: Jodan Ratz, PhD, Purdue Pharma, Canada

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2018
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Palonosetron
• Other Study ID Numbers: CAN-PRO-NEPA-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No