Olanzapine for Chemotherapy-induced Nausea and Vomiting P... | NCT04232423 | Trialant

Olanzapine for Chemotherapy-induced Nausea and Vomiting P... | NCT04232423 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OLN 0-5-10	Experimental	Placebo tablet in chemotherapy cycle 1, olanzapine 5 mg tablet in chemotherapy cycle 2, and olanzapine 10 mg tablet in chemotherapy cycle 3	Drug: Olanzapine 10 Mg ORAL TABLET Drug: Olanzapine 5 Mg ORAL TABLET Drug: Placebo ORAL TABLET
OLN 5-10-0	Experimental	Olanzapine 5 mg tablet in chemotherapy cycle 1, olanzapine 10 mg tablet in chemotherapy cycle 2, and placebo tablet in chemotherapy cycle 3	Drug: Olanzapine 10 Mg ORAL TABLET Drug: Olanzapine 5 Mg ORAL TABLET Drug: Placebo ORAL TABLET
OLN 10-0-5	Experimental	Olanzapine10 tablet in chemotherapy cycle 1, placebo tablet in chemotherapy cycle 2, and olanzapine 5 mg tablet in chemotherapy cycle 3	Drug: Olanzapine 10 Mg ORAL TABLET Drug: Olanzapine 5 Mg ORAL TABLET Drug: Placebo ORAL TABLET

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Olanzapine 10 Mg ORAL TABLET	Drug	Olanzapine 10 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) Olanzapine 10 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis	No breakthrough vomiting and no using rescue therapy	5 days after chemotherapeutic administration

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D004304	Dosage Forms
D004364	Pharmaceutical Preparations