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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEO-DXMS GROUP | Active Comparator | NEPA(1 capsule, day1, PO)+ Olanzapine(5mg, day1-4, PO)+ dexamethasone(12mg, day1; 8mg day2-4, PO/IV). |
|
| HALF-DXMS GROUP | Active Comparator | NEPA(1 capsule, day1, PO)+ Olanzapine(5mg, day1-4, PO)+ dexamethasone(6mg, day1, PO/IV) |
|
| NEO GROUP | Experimental | NEPA(1 capsule, day1, PO)+ Olanzapine(5mg, day1-4, PO). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netupitant / Palonosetron Oral Capsule [Akynzeo] | Drug | Akynzeo is the fixed-combination antiemetic comprising netupitant (neurokinin-1 receptor antagonist [NK1 RA]) and palonosetron (5-hydroxytryptamine-3 receptor antagonist [5-HT3 RA]). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 0-120 hours from the initiation of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the initiation of chemotherapy infusion(0h)up to beginning of day 6(-120 h) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Zhang, MD,PhD | Phase I Unit, Fudan University Shanghai Cancer Center, Shanghai, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Cancer | Shanghai | Shanghai Municipality | 200043 | China |
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| Olanzapine | Drug | 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 | Drug | synthetic glucocorticoids |
|
| 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). | 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). | 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 | 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. | From initiation of chemotherapy to 168 hours after initiation of chemotherapy |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C508854 | netupitant |
| D000077924 | Palonosetron |
| C000595957 | netupitant, palosentron drug combination |
| D000077152 | Olanzapine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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