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NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens
Sponsor: Fudan University
Summary
The objective of this Prospective, randomized, non inferiority phase III trial is to confirm the efficacy and saftey of dexamethasone-sparing combined with netupitant/palonostron and olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy.
Official title: Dexamethasone-sparing Based on Netupitant/Palonosetron(NEPA) With Olanzapine for the Effect of Chemotherapy-induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy: a Randomized Noninferiority III Phase Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
644
Start Date
2024-05-01
Completion Date
2025-08-30
Last Updated
2026-04-09
Healthy Volunteers
No
Interventions
Netupitant / Palonosetron Oral Capsule [Akynzeo]
Akynzeo is the fixed-combination antiemetic comprising netupitant (neurokinin-1 receptor antagonist \[NK1 RA\]) and palonosetron (5-hydroxytryptamine-3 receptor antagonist \[5-HT3 RA\]).
Olanzapine
Olanzapine is an effective antipsychotic drug used in psychiatry to treat psychoses, especially schizophrenia and schizoaffective disorders. It belongs to the 2nd generation antipsychotics, its mechanism of action ranks among multireceptor antagonists (MARTA); it affects the dopamine, serotonin, adrenaline, histamine, and muscarinic systems.
Dexamethasone Oral
synthetic glucocorticoids
Locations (1)
Fudan University Shanghai Cancer Cancer
Shanghai, Shanghai Municipality, China