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

Who is this study for? Adult patients with Chemotherapy-Induced Nausea or Vomiting
What treatments are being studied? Dexamethasone
Status: Completed
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Shanghai Chest Hospital
Shanghai
Shanghai Ninth People´s Hospital
Shanghai
Shanghai Obstetrics and Gynecology Hospital
Shanghai
Germany
Evang. Kliniken Essen-Mitte
Essen
Universitätsmedizin Mannheim
Mannheim
München Klinik Neuperlach
München
Frauenklinik St. Louise
Paderborn
Klinikum Ernst von Bergmann gemeinnützige GmbH
Potsdam
Greece
Sotiria General Hospital, 3rd Deúpartment of Medicine, School of Medicine, National and Kapodistrian University of Athens
Athens
General University Hospital of Heraklion
Heraklion
Spain
Complejo Hospitalario Universitario de A Coruña
A Coruña
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario de Salamanca
Salamanca
Switzerland
University Hospital Basel
Basel
Swiss Medical Network - Clinique de Genolier
Genolier
United Kingdom
The Royal Marsden Hospital
London
Time Frame
Start Date: 2021-02-01
Completion Date: 2024-07-02
Participants
Target number of participants: 414
Treatments
Experimental: NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
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.
Active_comparator: Standard of care + Dexamethasone 8 mg
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)
Related Therapeutic Areas
Sponsors
Leads: Helsinn Healthcare SA

This content was sourced from clinicaltrials.gov