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

NCT03649230 | Completed Results FDA Drug

• 1 other identifier: CAN-PRO-NEPA-001
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 17

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).

Conditions

Chemotherapy-Induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Complete Response

  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)

  Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days

Interventions

300mg netupitant/0.5mg palonosetron hydrochloride DRUG

Antiemetic (NK1 receptor antagonist/5-HT3 receptor antagonist)

Also known as: Akynzeo®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Purdue Pharma, Canada: lead

Study Sites (17)

Tom Baker Cancer Center

Calgary, Alberta, Canada

Location

The Moncton Hospital

Moncton, New Brunswick, Canada

Location

NSHA-QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Cape Breton Cancer Centre

Sydney, Nova Scotia, Canada

Location

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Location

William Osler Health System

Brampton, Ontario, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Location

Windsor Regional Cancer Centre

Windsor, Ontario, Canada

Location

Centre Integre de Sante et de Services Sociaux de la Monteregie-Centre

Greenfield Park, Quebec, Canada

Location

Cisss de Chaudiere-Appalaches

Lévis, Quebec, Canada

Location

Segal Cancer Centre-Jewish General Hospital

Montreal, Quebec, Canada

Location

Centre de recherche du CHUS and Hopital Fleurimont

Sherbrooke, Quebec, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Vomiting

Interventions

netupitant, palosentron drug combination

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was observational and open-label, lacking a control arm and randomization. Moreover, the study included mostly female patients and a high proportion of patients with breast or lung cancer, which may limit the generalizability of the study findings. Although "Quality of Life" data are subjective by nature, the FLIE questionnaire is validated, which minimizes the subjectivity of the patient-reported data.

Results Point of Contact

• Title: Graeme Donnelly
• Organization: Purdue Pharma (Canada)

graeme.donnelly@purdue.ca

905.837-6498

Study Officials

• Jodan Ratz, PhD

  Purdue Pharma, Canada

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 28, 2018
• Study Start: October 3, 2018
• Primary Completion: December 30, 2019
• Study Completion: January 30, 2020
• Last Updated: August 18, 2023
• Results First Posted: August 18, 2023

Record last verified: 2022-10

Locations

CA (17)