EVOLVE_CINV: Observational Study on the Use of Akynzeo® in Patients Receiving HEC
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Outcome Measures
Primary Outcome Measures
- Total Functional Living Index-Emesis (FLIE) score at cycle 1 [Day 5 of cycle 1]
The Functional Living Index - Emesis questionnaire is a patient reported outcome (PRO) validated tool 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 (where 1= no emesis-7=a great deal). Assessed by patient following day 5 of each cycle.
Secondary Outcome Measures
- Complete Response [daily Day 1-5]
No emetic episode and no use of rescue medication in the overall period (0-120h/Day 1-5)
- Severity of Nausea [daily day 1-5]
Severity of nausea assessed using a Visual Analogue Scale (VAS)
- Time to failure [daily Day 1-5]
time to first emetic episode or time to rescue
- incidence of treatment-Emergent Adverse Events [Safety and Tolerability] [daily though to study completion approximately 6 months]
Assessment of patient reported adverse events throughout the observational period
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
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Patient scheduled to receive a highly emetogenic chemotherapy (HEC).
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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.
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Age ≥ 18 years.
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Women of childbearing potential must use effective contraception during therapy and up to one month after treatment with Akynzeo®.
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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.
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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.
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Patient is participating in another clinical trial where antiemetic treatment is not pre-specified by the study protocol.
Exclusion Criteria:
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Women of child bearing potential who are pregnant, planning on becoming pregnant or breast feeding.
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Hypersensitivity to active substances, excipients or other ingredients of Akynzeo®.
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Concomitant use of pimozide, terfenadine, astemizole, or cisapride.
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Patient currently enrolled in another clinical trial where antiemetic treatment is pre-specified by the study protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tom Baker Cancer Center | Calgary | Alberta | Canada | |
| 2 | The Moncton Hospital | Moncton | New Brunswick | Canada | |
| 3 | NSHA-QEII Health Sciences Centre | Halifax | Nova Scotia | Canada | |
| 4 | Cape Breton Cancer Centre | Sydney | Nova Scotia | Canada | |
| 5 | Royal Victoria Regional Health Centre | Barrie | Ontario | Canada | |
| 6 | William Osler Health System | Brampton | Ontario | Canada | |
| 7 | Grand River Regional Cancer Centre | Kitchener | Ontario | Canada | |
| 8 | London Health Sciences Centre | London | Ontario | Canada | |
| 9 | Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario | Canada | |
| 10 | St. Michael's Hospital | Toronto | Ontario | Canada | |
| 11 | Sunnybrook Health Sciences Center | Toronto | Ontario | Canada | |
| 12 | Windsor Regional Cancer Centre | Windsor | Ontario | Canada | |
| 13 | Centre Integre de Sante et de Services Sociaux de la Monteregie-Centre | Greenfield Park | Quebec | Canada | |
| 14 | Cisss de Chaudiere-Appalaches | Lévis | Quebec | Canada | |
| 15 | Segal Cancer Centre-Jewish General Hospital | Montréal | Quebec | Canada | |
| 16 | Centre de recherche du CHUS and Hopital Fleurimont | Sherbrooke | Quebec | Canada | |
| 17 | Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada |
Sponsors and Collaborators
- Purdue Pharma, Canada
Investigators
- Study Director: Jodan Ratz, PhD, Purdue Pharma, Canada
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAN-PRO-NEPA-001