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

NCT04817189 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2025-12-02

Study results available
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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:

1. nausea and/or vomiting in the prior cycle of chemotherapy
2. use of non-prescribed antiemetics at home in the prior cycle of chemotherapy
3. platinum or anthracycline-based chemotherapy
4. age \< 60 years
5. expectations for (anticipating) nausea and/or vomiting
6. \<7 h of sleep the night before chemotherapy
7. history of morning sickness during previous pregnancy
8. 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.

Conditions

  • Chemotherapy-induced Nausea and Vomiting

Interventions

DRUG

NEPA (300mg netupitant/0.5mg palonosetron)

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

DRUG

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)

Standard of care will be administered on Day 1 of each cycle.

DRUG

Dexamethasone, 8 mg (oral) or equivalent IV dose

Dexamethasone (8 mg) will be administered on Day 1 of each cycle.

Sponsors & Collaborators

  • Helsinn Healthcare SA

    lead INDUSTRY

Principal Investigators

  • Alex Molasiotis, prof. · University of Derby

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2024-07-02
Completion
2024-07-02

Countries

  • China
  • Czechia
  • Germany
  • Greece
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04817189 on ClinicalTrials.gov