Chemotherapy-Induced Nausea and VomitingEVOLVE_CINVNCT03649230

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

An observational study of Chemotherapy-Induced Nausea and Vomiting, run by Purdue Pharma, Canada at 17 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chemotherapy-Induced Nausea and Vomiting
What is being tested?: 300mg netupitant/0.5mg palonosetron hydrochloride
How many people: 207 participants
Where: 17 sitesCanada
Study dates: 3 Oct 2018to 30 Jan 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

Canada17 sites

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

Other trials in Canada

About this study

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.

Read the 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).

Conditions: Chemotherapy-Induced Nausea and Vomiting
Being tested: 300mg netupitant/0.5mg palonosetron hydrochloride
Medical subject headings: Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

300mg netupitant/0.5mg palonosetron hydrochlorideDrug
Also called Akynzeo®
Antiemetic (NK1 receptor antagonist/5-HT3 receptor antagonist)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 5 of cycle 1

Secondary outcomes (2)

Complete Response
No emetic episode and no use of rescue medication in the overall period (0-120h/Day 1-5)
Measured: 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").
Measured: Days 1-5 (0 - 120 hours) of cycles 1, 2, 3, 4; each cycle is approximately 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 201830 Jan 2020

First posted28 Aug 2018
Study start3 Oct 2018
Primary completion30 Dec 2019
Study completion30 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chemotherapy-Induced Nausea and VomitingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03649230
Sponsor's protocol ID: CAN-PRO-NEPA-001
Acronym: EVOLVE_CINV
Status last verified: Oct 2022
First submitted: 23 Aug 2018
Last updated: 18 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingPhase 2
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Breast Cancer
RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea
RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV)

All Chemotherapy-Induced Nausea and Vomiting trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT03649230
Acronym / sponsor ID: EVOLVE_CINV / CAN-PRO-NEPA-001
Conditions: Chemotherapy-Induced Nausea and Vomiting
Study type: Observational
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Purdue Pharma, CanadaIndustry (pharma, biotech, devices)
Study start: 3 Oct 2018 (actual)
Primary completion: 30 Dec 2019 (actual)
Study completion: 30 Jan 2020 (actual)
First posted: 28 Aug 2018 (actual)
Results: Posted 18 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
300mg netupitant/0.5mg palonosetron hydrochlorideAlso: Akynzeo®Antiemetic (NK1 receptor antagonist/5-HT3 receptor antagonist)	Drug	–

Primary outcome

Total Functional Living Index-Emesis (FLIE) Score at Cycle 1
Time frame: Day 5 of 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.

2 secondary outcomes

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

Results and safety

Results posted to the registry on 18 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	207	150

Primary outcome: Total Functional Living Index-Emesis (FLIE) Score at Cycle 1

Time frame: Day 5 of cycle 1. Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment n = 184
Value	109.2 (17.7)

Population analysed: mITT

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The visit schedule was comprised of six study visits: • Visit 1/Screening (4 weeks to 0 weeks prior to Visit 2) • Visit 2: (Day of/but prior to 1st chemotherapy treatment administration) • Visit 3: (Day of/but prior to 2nd chemotherapy treatment administration) • Visit 4: (Day of/but prior to 3rd, chemotherapy treatment administration) • Visit 5: (Day of/but prior to 4th, chemotherapy treatment administration) • Visit 6/Final Visit. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	39 of 197 (19.8%)	178 of 197 (90.4%)	9 of 197

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chemotherapy-Induced Nausea and Vomiting

RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingPhase 2
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Breast Cancer
RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea
RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jodan Ratz, PhD study director

Purdue Pharma, Canada

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chemotherapy-Induced Nausea and Vomiting, run by Purdue Pharma, Canada at 17 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Functional Living Index-Emesis (FLIE) Score at Cycle 1 (time frame: Day 5 of cycle 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03649230.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.