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This aim of study is to evaluate the safety and efficacy of olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy by a randomized, double-blind, placebo-controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | palonosetron + dexamethasone + placebo | |
| Experimental | Experimental | palonosetron + dexamethasone + olanzapine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete response rate for the acute phase (0-24 hours) after chemotherapy | during 24 hours after first cycle of moderately emetogenic chemotherapy (MEC) |
| Measure | Description | Time Frame |
|---|---|---|
| complete response rate for the delayed phase (24-120 hours) and overall phase (0-120 hours) after chemotherapy | during 0-120 hours after first cycle of MEC | |
| no vomiting for the overall phase | during 0-120 hours after first cycle of MEC |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jooyoung Lee | Contact | 82-42-280-7399 | poppoya99@naver.com |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| significant emesis for the overall phase | during 0-120 hours after first cycle of MEC |
| numbers and time for rescue medicaions | during 0-120 hours after first cycle of MEC |
| effects on quality of life by FLIE questionnaire | during 0-120 hours after first cycle of MEC |
| D006571 | Heterocyclic Compounds |