Clinical trial NCT03649230: Observational Study on the Use of Akynzeo® in Patients Receiving HEC
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-Induced Nausea and Vomiting
Lead sponsor: Purdue Pharma, Canada
Sponsor class: INDUSTRY
First posted: 2018-08-28
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Total Functional Living Index-Emesis (FLIE) Score at Cycle 1
timeFrame: Day 5 of cycle 1
Secondary outcomes:
measure: Complete Response
timeFrame: Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days
measure: Severity of Nausea on Day 5 (Change From Day 1)
timeFrame: Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Moncton
country: Canada
facility: The Moncton Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: NSHA-QEII Health Sciences Centre
state: Nova Scotia
city: Sydney
country: Canada
facility: Cape Breton Cancer Centre
state: Nova Scotia
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Brampton
country: Canada
facility: William Osler Health System
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Regional Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre
state: Ontario
city: Greenfield Park
country: Canada
facility: Centre Integre de Sante et de Services Sociaux de la Monteregie-Centre
state: Quebec
city: Lévis
country: Canada
facility: Cisss de Chaudiere-Appalaches
state: Quebec
city: Montréal
country: Canada
facility: Segal Cancer Centre-Jewish General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre de recherche du CHUS and Hopital Fleurimont
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
Study officials:
affiliation: Purdue Pharma, Canada
name: Jodan Ratz, PhD
role: STUDY_DIRECTOR
References: