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Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) (CINV)

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
NEPA (300mg netupitant/0.5mg palonosetron)
Granisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral), 0.25mg (IV) OR Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or IV)
Dexamethasone, 8 mg (oral) or equivalent IV dose
Sponsored by
Helsinn Healthcare SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients aged ≥18 years
  • Patients with a risk score of ≥ 13 as calculated by the algorithm - see 3.6.3.1. Baseline/screening: VISIT 0
  • Signed Informed consent
  • Both sexes
  • Patients with diagnosis of any cancer scheduled and intended to be treated for three consecutive cycles with a single dose of any IV MEC regimen, per cycle, including adjuvant or neo-adjuvant chemotherapy
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Use of Standard of Care defined as a 5-HT3 RA + Dexamethasone (or equivalent corticosteroid) based-regimen on day 1 of chemotherapy for CINV prevention
  • Naïve and non- naïve to chemotherapy
  • The enrolled women should be a) of non-childbearing potential or b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test done by health care team within 1-24 hours before dosing the antiemetic treatment in both arms and outcome recorded in the medical records
  • Able to comply with study requirements

Exclusion Criteria:

  • Patients receiving highly emetogenic chemotherapy (including anthracycline+cyclophosphamide-based chemotherapy)
  • Patients receiving oral moderately emetogenic chemotherapy drugs
  • Patients receiving opioids within 2 weeks prior to trial enrollment (longer use allowed)
  • Use of olanzapine as prophylaxis of CINV
  • Patients scheduled to receive radiotherapy concurrently with chemotherapy
  • Any illness or condition that, in the opinion of the physician, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient.
  • Patients with mechanical risk factors for nausea (i.e. intestinal obstruction)
  • Patients with liver disease (as nausea is a common presenting symptom)
  • Patients with metabolic risk factors for nausea (i.e. electrolyte imbalances causing nausea/vomiting)
  • Chronic treatment with steroids (with the exception of inhaled or topical steroids)
  • Pregnancy and/or breast-feeding women
  • Women of childbearing potential refusing to use effective contraception during the whole study treatment and up to one month after study treatment with Akynzeo®
  • Use of Standard of Care including an NK-1 RA-based regimen to prevent CINV

Sites / Locations

  • Shanghai Chest HospitalRecruiting
  • Shanghai Ninth People´s HospitalRecruiting
  • Shanghai Obstetrics and Gynecology HospitalRecruiting
  • General University Hospital in Prague
  • Thomayerova nemocnice
  • Evang. Kliniken Essen-Mitte
  • IKF Frankfurt, Krankenhaus Nordwest GmbH
  • Universitätsklinikum Heidelberg
  • Universitätsmedizin Mannheim
  • München Klinik Neuperlach
  • Frauenklinik St. Louise
  • Klinikum Ernst von Bergmann gemeinnützige GmbH
  • Sotiria General Hospital, 3rd Deúpartment of Medicine, School of Medicine, National and Kapodistrian University of AthensRecruiting
  • General University Hospital of HeraklionRecruiting
  • Complejo Hospitalario Universitario de A CoruñaRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital General Universitario Gregorio MarañónRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • University Hospital Basel
  • Swiss Medical Network - Clinique de Genolier
  • The Royal Marsden Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg

Standard of care + Dexamethasone 8 mg

Arm Description

Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle. Dexamethasone (8 mg) will be administered on Day 1 of each cycle.

Dexamethasone (or equivalent corticosteroids) 8 mg administered by the oral route (or equivalent IV dose) on Day 1, approximately 1 hour before chemotherapy and one of the 5-HT3-RAs recommended by European Society for Medical Oncology (ESMO) and Multinational Association of Supportive Care in Cancer (MASCC) guidelines (standard of care), i.e. either: Granisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral), 0.25mg (IV) OR Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or IV)

Outcomes

Primary Outcome Measures

The proportion of complete responses over three cycles of chemotherapy after the start of the MEC administration
To evaluate if the use of NEPA (netupitant and palonosetron) in patients treated with IV moderately emetogenic chemotherapy and at high risk of CINV is more effective in preventing CINV than a standard of care antiemetics over three cycles of chemotherapy.

Secondary Outcome Measures

Evaluation of acute (0 to 24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) CINV indicators in each cycle of chemotherapy
Proportion of: No emetic episode during the acute, delayed, and overall phase and daily in each cycle Number of vomiting episodes during the acute, delayed, and overall phase in each cycle No rescue medication during the acute, delayed, and overall phase and daily in each cycle No significant nausea (maximum MAT scale = 2) during the acute, delayed, and overall phase and daily in each cycle; No nausea (MAT scale = 0) during the acute, delayed, and overall phase and daily in each cycle; Complete protection (no emetic episode, no rescue medication, and no significant nausea) during the acute, delayed, and overall phase and daily in each cycle Time 0 is defined as the start time of the chemotherapy administration on Day 1 of each of the three cycles.
Evaluation of the predictive role of potential risk factors in the development of CINV over three cycles of chemotherapy
Analysis of the development of CINV as a dependent variable will be performed to identify additional potential risk factors of CINV thought to be increasing the risk of CINV in patients receiving MEC. The outcome measure is the development of CINV, defined as any occurrence of nausea or a vomiting episode. The data on the development of CINV will be taken from data collection tools, patients' diaries and MASCC Antiemesis Tool (MAT).
Evaluation of the safety profile of the antiemetic drug over three cycles of chemotherapy - the frequency of adverse events (AE)
An overall summary of adverse events (AE) will be presented, including the frequency of patients with: Any treatment-emergent adverse event Any treatment-emergent adverse event related to a study drug Any treatment-emergent adverse event leading to chemotherapy dose reductions or interruptions Any treatment-emergent serious adverse event All AEs will be summarized by their: Severity Seriousness Relationship to a drug
Evaluation of the safety profile of the antiemetic drug over three cycles of chemotherapy - the percentage of adverse events (AE)
An overall summary of adverse events (AE) will be presented, including the percentage of patients with: Any treatment-emergent adverse event Any treatment-emergent adverse event related to a study drug Any treatment-emergent adverse event leading to chemotherapy dose reductions or interruptions Any treatment-emergent serious adverse event All AEs will be summarized by their: Severity Seriousness Relationship to a drug
Evaluation of the frequency of discontinuations due to adverse events
The frequency of discontinuations due to adverse events (AE) will be presented. All AEs leading to discontinuation will be summarized by their: Severity Seriousness Relationship to a drug
Evaluation of the percentage of discontinuations due to adverse events
The percentage of patients with discontinuations due to adverse events (AE) will be presented. All AEs leading to discontinuation will be summarized by their: Severity Seriousness Relationship to a drug
Evaluation of frequency of on treatment deaths due to adverse events
The frequency of on treatment deaths due to adverse events (AE) will be presented. All AEs leading to on treatment deaths will be summarized by their: Severity Seriousness Relationship to a drug
Evaluation of the percentage of patients with on treatment death due to adverse events
The percentage of patients with on treatment death due to adverse events (AE) will be presented. All AEs leading to on treatment death will be summarized by their: Severity Seriousness Relationship to a drug
Listings concerning the safety profile of the antiemetic drug over three cycles of chemotherapy
The following listings will be presented: All AEs (including pre-treatment AEs) Serious adverse events Adverse events resulting in withdrawn of study drug
Exploration of the effect of CINV on daily activities and quality of life in patients receiving moderately-emetogenic chemotherapy over three cycles of chemotherapy
Evaluation of the effect of CINV on daily activities and quality of life that will be measured by using the Functional Living Index-Emesis (FLIE) questionnaire, a validated, nausea and vomiting specific, patient-reported outcome instrument. The Functional Living Index-Emesis (FLIE) has 18 questions. These questions are divided into two domains: Nausea (questions 1-9) and Vomiting (questions 10-18). The minimum score for any question is 0 and the maximum score is 100. Higher scores indicate less impairment on daily life as a result of nausea or vomiting.
Evaluation of resource utilization and health economic outcome - number of days with rescue medication administered for the treatment of CINV
Health economic endpoint, the number of days with rescue medication administered for the treatment of CINV, will be evaluated during the study cycles
Evaluation of resource utilization and health economic outcome - daily doses of rescue medication administered for the treatment of CINV
Health economic endpoint, the daily doses of rescue medication administered for the treatment of CINV, will be evaluated during the study cycles
Evaluation of resource utilization and health economic outcome - the number of re-hydration bags
Health economic endpoint, the number of re-hydration bags given for at least grade 2 vomiting (more details below), will be evaluated during the study cycles
Evaluation of resource utilization and health economic outcome - the number of days of unplanned hospitalisations
Health economic endpoint, the number of days of unplanned hospitalizations related to CINV, will be evaluated during the study cycles All hospitalizations will be summarized according to the department of hospitalization (type of ward)
Evaluation of resource utilization and health economic outcome - the number of outpatient physician visits
Health economic endpoint, the number of outpatient physician visits and health care consultations due to CINV (e.g., general practitioner), will be evaluated during the study cycles
Evaluation of resource utilization and health economic outcome - the number of unplanned laboratory test
Health economic endpoint, the number of unplanned laboratory test including those at unplanned hospitalizations due to CINV, will be evaluated during the study cycles
Evaluation of resource utilization and health economic outcome - discontinuation of chemotherapy treatment due to CINV
Health economic endpoint, the number of discontinuations of chemotherapy treatment due to CINV, will be evaluated during the study cycles
Evaluation of resource utilization and health economic outcome - the number of delays of chemotherapy administration due to CINV
Health economic endpoint, the number of delays of chemotherapy administration due to CINV, will be evaluated during the study cycles
Evaluation of resource utilization and health economic outcome - the average length of delay of chemotherapy administration due to CINV
Health economic endpoint, the average length of delay (in days) of chemotherapy administration due to CINV, will be evaluated during the study cycles
Evaluation of resource utilization and health economic outcome - days of absence from work
Health economic endpoint, the number of days of absence from work, will be evaluated during the study cycles

Full Information

First Posted
March 1, 2021
Last Updated
August 31, 2023
Sponsor
Helsinn Healthcare SA
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1. Study Identification

Unique Protocol Identification Number
NCT04817189
Brief Title
Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk)
Acronym
CINV
Official Title
MyRisk: Efficacy and Safety Evaluation of Oral Akynzeo® in Patients Receiving MEC at High Risk of Developing CINV Based on a Prediction Tool: A Multinational and Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helsinn Healthcare SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
MyRisk: Efficacy and safety evaluation of oral Akynzeo® in patients receiving MEC at high risk of developing CINV based on a prediction tool. A multinational and multicenter study. Antiemetic guidelines recommendations are based on the emetogenic potential of the chemotherapy. Chemotherapy (CT) agents are divided in Highly, Moderately, Low and Minimally Emetogenic potential. In addition to type of chemotherapy, several patient-related risk factors can increase the risk of CINV (chemotherapy-induced nausea and vomiting). Currently, there is limited consensus surrounding the most relevant patient risk factors that may predict the risk of CINV. Based on a recent study by Dranitsaris et al. (Dranitsaris et al. Ann Oncol. 2017 Jun 1; 28(6):1260-1267.), eight (8) predictive factors have been identified and an algorithm has been developed to incorporate these factors into the optimal selection of prophylactic antiemetics: nausea and/or vomiting in the prior cycle of chemotherapy use of non-prescribed antiemetics at home in the prior cycle of chemotherapy platinum or anthracycline-based chemotherapy age < 60 years expectations for (anticipating) nausea and/or vomiting <7 h of sleep the night before chemotherapy history of morning sickness during previous pregnancy cycle of chemotherapy (A negative association between risk and number of cycles was identified where the hazard for CINV was highest in cycles 1 and 2, with a gradual decline and plateau from cycle 3 onward). The clinical application of this prediction tool has the potential to be an important resource for clinicians and may help to enhance patient care by optimizing the use of the antiemetics in a proactive manner.
Detailed Description
Antiemetic guideline recommendations are based on the emetogenic potential of chemotherapy and involve 4 levels of classification of intravenous chemotherapy agents, i.e., high, moderate, low and minimal; these have been accepted by major organisations. Moderate emetogenic chemotherapy (MEC) results in acute vomiting in 30% to 90% of cancer patients in the absence of antiemetic therapy. In addition to the chemotherapy type, several patient-related risk factors and clinical characteristics can increase CINV risk. These can include use of antiemetics inconsistent with international guidelines, younger age, prechemotherapy nausea, no complete CINV response in an earlier cycle, history of nausea/vomiting, (trait) anxiety, fatigue experience, and expectations of nausea/vomiting. Other studies have largely confirmed some of the key risk factors for CINV (history of vomiting during pregnancy, history of motion sickness, age, gender) and added other factors such as (chronic) alcohol consumption, body surface area, fewer hours slept the night prior to infusion, or advanced stage cancer. Currently, there is a limited consensus surrounding the most relevant patient risk factors that may predict CINV risk. Based on a recent study by Dranitsaris et al. eight predictive factors have been identified, and an algorithm has been developed to combine these patient-related risk factors into the optimal treatment of prophylactic antiemetics. These include: nausea and/or vomiting in the prior cycle of chemotherapy use of non-prescribed antiemetics at home in the prior cycle of chemotherapy platinum or anthracycline-based chemotherapy age < 60 years expectations for (anticipating) nausea and/or vomiting <7 h of sleep the night before chemotherapy history of morning sickness during previous pregnancy cycle of chemotherapy (A negative association between risk and number of cycles was identified where the hazard for CINV was highest in cycles 1 and 2, with a gradual decline and plateau from cycle 3 onward). Akynzeo®, an oral combination of the neurokinin 1 receptor antagonists (NK1 RA), netupitant and the 5-hydroxytryptamine (HT3) receptor antagonists (5-HT3 RA), palonosetron, is recommended by guidelines for the prevention of CINV. Akynzeo® has been evaluated in a multicentre, randomised, double-blind, double-dummy phase II clinical trial at various dose ranges among 694 cisplatin-treated cancer patients from 44 sites (two countries); each NEPA (netupitant-palonosetron) dose significantly improves CINV prevention in cancer patients. Similar results were obtained in another international, randomised, double-blind and parallel group phase III clinical trial; NEPA prevented CINV in patients receiving MEC. The current study primarily aimed to evaluate whether Akynzeo® leads to a higher response rate compared with standard care in MEC regimen-treated patients who are identified to be at high risk based on the algorithm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
interventional, open label, randomized, active controlled, parallel arms, multicenter and multinational study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
530 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
Arm Type
Experimental
Arm Description
Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle. Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
Arm Title
Standard of care + Dexamethasone 8 mg
Arm Type
Active Comparator
Arm Description
Dexamethasone (or equivalent corticosteroids) 8 mg administered by the oral route (or equivalent IV dose) on Day 1, approximately 1 hour before chemotherapy and one of the 5-HT3-RAs recommended by European Society for Medical Oncology (ESMO) and Multinational Association of Supportive Care in Cancer (MASCC) guidelines (standard of care), i.e. either: Granisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral), 0.25mg (IV) OR Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or IV)
Intervention Type
Drug
Intervention Name(s)
NEPA (300mg netupitant/0.5mg palonosetron)
Other Intervention Name(s)
Akynzeo® capsules
Intervention Description
Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
Intervention Type
Drug
Intervention Name(s)
Granisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral), 0.25mg (IV) OR Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or IV)
Other Intervention Name(s)
5-HT3 RA
Intervention Description
Standard of care will be administered on Day 1 of each cycle.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone, 8 mg (oral) or equivalent IV dose
Other Intervention Name(s)
corticosteroid
Intervention Description
Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
Primary Outcome Measure Information:
Title
The proportion of complete responses over three cycles of chemotherapy after the start of the MEC administration
Description
To evaluate if the use of NEPA (netupitant and palonosetron) in patients treated with IV moderately emetogenic chemotherapy and at high risk of CINV is more effective in preventing CINV than a standard of care antiemetics over three cycles of chemotherapy.
Time Frame
At the end of all three chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Secondary Outcome Measure Information:
Title
Evaluation of acute (0 to 24 hours), delayed (>24 to 120 hours), and overall (0-120 hours) CINV indicators in each cycle of chemotherapy
Description
Proportion of: No emetic episode during the acute, delayed, and overall phase and daily in each cycle Number of vomiting episodes during the acute, delayed, and overall phase in each cycle No rescue medication during the acute, delayed, and overall phase and daily in each cycle No significant nausea (maximum MAT scale = 2) during the acute, delayed, and overall phase and daily in each cycle; No nausea (MAT scale = 0) during the acute, delayed, and overall phase and daily in each cycle; Complete protection (no emetic episode, no rescue medication, and no significant nausea) during the acute, delayed, and overall phase and daily in each cycle Time 0 is defined as the start time of the chemotherapy administration on Day 1 of each of the three cycles.
Time Frame
At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of the predictive role of potential risk factors in the development of CINV over three cycles of chemotherapy
Description
Analysis of the development of CINV as a dependent variable will be performed to identify additional potential risk factors of CINV thought to be increasing the risk of CINV in patients receiving MEC. The outcome measure is the development of CINV, defined as any occurrence of nausea or a vomiting episode. The data on the development of CINV will be taken from data collection tools, patients' diaries and MASCC Antiemesis Tool (MAT).
Time Frame
At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of the safety profile of the antiemetic drug over three cycles of chemotherapy - the frequency of adverse events (AE)
Description
An overall summary of adverse events (AE) will be presented, including the frequency of patients with: Any treatment-emergent adverse event Any treatment-emergent adverse event related to a study drug Any treatment-emergent adverse event leading to chemotherapy dose reductions or interruptions Any treatment-emergent serious adverse event All AEs will be summarized by their: Severity Seriousness Relationship to a drug
Time Frame
At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of the safety profile of the antiemetic drug over three cycles of chemotherapy - the percentage of adverse events (AE)
Description
An overall summary of adverse events (AE) will be presented, including the percentage of patients with: Any treatment-emergent adverse event Any treatment-emergent adverse event related to a study drug Any treatment-emergent adverse event leading to chemotherapy dose reductions or interruptions Any treatment-emergent serious adverse event All AEs will be summarized by their: Severity Seriousness Relationship to a drug
Time Frame
At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of the frequency of discontinuations due to adverse events
Description
The frequency of discontinuations due to adverse events (AE) will be presented. All AEs leading to discontinuation will be summarized by their: Severity Seriousness Relationship to a drug
Time Frame
At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of the percentage of discontinuations due to adverse events
Description
The percentage of patients with discontinuations due to adverse events (AE) will be presented. All AEs leading to discontinuation will be summarized by their: Severity Seriousness Relationship to a drug
Time Frame
At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of frequency of on treatment deaths due to adverse events
Description
The frequency of on treatment deaths due to adverse events (AE) will be presented. All AEs leading to on treatment deaths will be summarized by their: Severity Seriousness Relationship to a drug
Time Frame
At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of the percentage of patients with on treatment death due to adverse events
Description
The percentage of patients with on treatment death due to adverse events (AE) will be presented. All AEs leading to on treatment death will be summarized by their: Severity Seriousness Relationship to a drug
Time Frame
At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Listings concerning the safety profile of the antiemetic drug over three cycles of chemotherapy
Description
The following listings will be presented: All AEs (including pre-treatment AEs) Serious adverse events Adverse events resulting in withdrawn of study drug
Time Frame
At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Exploration of the effect of CINV on daily activities and quality of life in patients receiving moderately-emetogenic chemotherapy over three cycles of chemotherapy
Description
Evaluation of the effect of CINV on daily activities and quality of life that will be measured by using the Functional Living Index-Emesis (FLIE) questionnaire, a validated, nausea and vomiting specific, patient-reported outcome instrument. The Functional Living Index-Emesis (FLIE) has 18 questions. These questions are divided into two domains: Nausea (questions 1-9) and Vomiting (questions 10-18). The minimum score for any question is 0 and the maximum score is 100. Higher scores indicate less impairment on daily life as a result of nausea or vomiting.
Time Frame
At the end of all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of resource utilization and health economic outcome - number of days with rescue medication administered for the treatment of CINV
Description
Health economic endpoint, the number of days with rescue medication administered for the treatment of CINV, will be evaluated during the study cycles
Time Frame
At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of resource utilization and health economic outcome - daily doses of rescue medication administered for the treatment of CINV
Description
Health economic endpoint, the daily doses of rescue medication administered for the treatment of CINV, will be evaluated during the study cycles
Time Frame
At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of resource utilization and health economic outcome - the number of re-hydration bags
Description
Health economic endpoint, the number of re-hydration bags given for at least grade 2 vomiting (more details below), will be evaluated during the study cycles
Time Frame
At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of resource utilization and health economic outcome - the number of days of unplanned hospitalisations
Description
Health economic endpoint, the number of days of unplanned hospitalizations related to CINV, will be evaluated during the study cycles All hospitalizations will be summarized according to the department of hospitalization (type of ward)
Time Frame
At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of resource utilization and health economic outcome - the number of outpatient physician visits
Description
Health economic endpoint, the number of outpatient physician visits and health care consultations due to CINV (e.g., general practitioner), will be evaluated during the study cycles
Time Frame
At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of resource utilization and health economic outcome - the number of unplanned laboratory test
Description
Health economic endpoint, the number of unplanned laboratory test including those at unplanned hospitalizations due to CINV, will be evaluated during the study cycles
Time Frame
At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of resource utilization and health economic outcome - discontinuation of chemotherapy treatment due to CINV
Description
Health economic endpoint, the number of discontinuations of chemotherapy treatment due to CINV, will be evaluated during the study cycles
Time Frame
At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of resource utilization and health economic outcome - the number of delays of chemotherapy administration due to CINV
Description
Health economic endpoint, the number of delays of chemotherapy administration due to CINV, will be evaluated during the study cycles
Time Frame
At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of resource utilization and health economic outcome - the average length of delay of chemotherapy administration due to CINV
Description
Health economic endpoint, the average length of delay (in days) of chemotherapy administration due to CINV, will be evaluated during the study cycles
Time Frame
At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).
Title
Evaluation of resource utilization and health economic outcome - days of absence from work
Description
Health economic endpoint, the number of days of absence from work, will be evaluated during the study cycles
Time Frame
At the end of each cycle and after all 3 chemotherapy cycles. The length of a cycle depends on the treatment being given (cycles range from 2 to 6 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients aged ≥18 years Patients with a risk score of ≥ 13 as calculated by the algorithm - see 3.6.3.1. Baseline/screening: VISIT 0 Signed Informed consent Both sexes Patients with diagnosis of any cancer scheduled and intended to be treated for three consecutive cycles with a single dose of any IV MEC regimen, per cycle, including adjuvant or neo-adjuvant chemotherapy Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 Use of Standard of Care defined as a 5-HT3 RA + Dexamethasone (or equivalent corticosteroid) based-regimen on day 1 of chemotherapy for CINV prevention Naïve and non- naïve to chemotherapy The enrolled women should be a) of non-childbearing potential or b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test done by health care team within 1-24 hours before dosing the antiemetic treatment in both arms and outcome recorded in the medical records Able to comply with study requirements Exclusion Criteria: Patients receiving highly emetogenic chemotherapy (including anthracycline+cyclophosphamide-based chemotherapy) Patients receiving oral moderately emetogenic chemotherapy drugs Patients receiving opioids within 2 weeks prior to trial enrollment (longer use allowed) Use of olanzapine as prophylaxis of CINV Patients scheduled to receive radiotherapy concurrently with chemotherapy Any illness or condition that, in the opinion of the physician, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient. Patients with mechanical risk factors for nausea (i.e. intestinal obstruction) Patients with liver disease (as nausea is a common presenting symptom) Patients with metabolic risk factors for nausea (i.e. electrolyte imbalances causing nausea/vomiting) Chronic treatment with steroids (with the exception of inhaled or topical steroids) Pregnancy and/or breast-feeding women Women of childbearing potential refusing to use effective contraception during the whole study treatment and up to one month after study treatment with Akynzeo® Use of Standard of Care including an NK-1 RA-based regimen to prevent CINV
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Alonzi, MSc.
Phone
+41 91 985 18 81
Email
Alessandro.Alonzi@helsinn.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marika Chrápavá, MSc.
Phone
+420 605 550 715
Email
chrapava@biostatistika.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Molasiotis, prof.
Organizational Affiliation
University of Derby
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Zhou
Facility Name
Shanghai Ninth People´s Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyong Tu
Facility Name
Shanghai Obstetrics and Gynecology Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Lu
Facility Name
General University Hospital in Prague
City
Prague
Country
Czechia
Individual Site Status
Active, not recruiting
Facility Name
Thomayerova nemocnice
City
Praha
ZIP/Postal Code
14059
Country
Czechia
Individual Site Status
Completed
Facility Name
Evang. Kliniken Essen-Mitte
City
Essen
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
IKF Frankfurt, Krankenhaus Nordwest GmbH
City
Frankfurt
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsmedizin Mannheim
City
Mannheim
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
München Klinik Neuperlach
City
München
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Frauenklinik St. Louise
City
Paderborn
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Klinikum Ernst von Bergmann gemeinnützige GmbH
City
Potsdam
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Sotiria General Hospital, 3rd Deúpartment of Medicine, School of Medicine, National and Kapodistrian University of Athens
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos Syrigos, Prof.
Phone
0030 2107700220
Email
ksyrigos.trials@gmail.com
Facility Name
General University Hospital of Heraklion
City
Heraklion
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitris Mavroudis, professor
Phone
0030 2810392091
Email
mavroudis@uoc.gr
Facility Name
Complejo Hospitalario Universitario de A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Maria Vázguez
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
0802
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margarita Majem Tarruella
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilar García Alfonso
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
César Augusto Rodríguez
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland
Individual Site Status
Terminated
Facility Name
Swiss Medical Network - Clinique de Genolier
City
Genolier
Country
Switzerland
Individual Site Status
Terminated
Facility Name
The Royal Marsden Hospital
City
London
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Tomlins

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk)

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