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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
644
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 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.
synthetic glucocorticoids
Fudan University Shanghai Cancer Cancer
Shanghai, Shanghai Municipality, China
Percentage of patients with complete response (CR)
Percentage of patients with complete response (CR) defined defined as no vomiting with no use of rescue therapy
Time frame: Within 0-120 hours from the initiation of chemotherapy
Percentage of Patients With CR (acute and delayed)
Percentage of patients with complete response (CR) defined defined as no vomiting with no use of rescue therapy "Acute"period referred to 0-24 h after the initiation of chemotherapy,"delayed"period referred to 24-120 h.
Time frame: From the initiation of chemotherapy infusion(0h)up to beginning of day 6(-120 h)
Percentage of patients with overall complete protection(OCP)
Percentage of patients with overall complete protection(OCP) defined as no emesis, no rescue medication and able mild nausea(VAS≤25mm).
Time frame: During the acute (within 24 hours post-chemotherapy) and delayed (days 2 thorough 5) phases of chemotherapy
Percentage of patients with overall total control (OTC)
Percentage of patients with overall total control (OTC) defined as no emesis, no rescue medication and no nausea(VAS≤5mm).
Time frame: During 0 ~ 24 hours and 0 ~ 168 hours post-chemotherapy
incidence of adverse events
Adverse event s were graded according to NCI CTCAE v 5.0
Time frame: From initiation of chemotherapy to 168 hours after initiation of chemotherapy
quality of life questionnaire
Quality of life(QoL) was evaluated by the Chinese version of the self reported Functional Living Index-Emesis (FLIE) questionnaire by individual patients.
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Time frame: From initiation of chemotherapy to 168 hours after initiation of chemotherapy