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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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.

Conditions
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Chemotherapy-Induced Nausea and Vomiting

Intervention / Treatment
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* Drug: 300mg netupitant/0.5mg palonosetron hydrochloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 300mg netupitant/0.5mg palonosetron hydrochloride|Antiemetic (NK1 receptor antagonist/5-HT3 receptor antagonist)|

What is the study measuring?
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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 |