Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) (CINV)
Chemotherapy-induced Nausea and Vomiting
About this trial
This is an interventional supportive care trial for Chemotherapy-induced Nausea and Vomiting
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
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
Experimental
Active Comparator
NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg
Standard of care + 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.
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)