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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03649230
Other study ID # CAN-PRO-NEPA-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 3, 2018
Est. completion date January 30, 2020

Study information

Verified date October 2022
Source Purdue Pharma, Canada
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 207
Est. completion date January 30, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Purdue Pharma, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
See also
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