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This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1 | Experimental | 1st cycle Palonosetron, 2nd cycle Granisetron |
|
| Arm2 | Experimental | 1st cycle Granisetron, 2nd cycle Palonosetron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palonosetron | Drug | Palonosetron 0.25mg d1,d3 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response(CR) within 24-120 hours after chemotherapy | 24-120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| CR within 0-120 hours after chemotherapy | 0-120 hours | |
| CR within 0-24 hours after chemotherapy | 0-24 hours | |
| Incidence of Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiying Yu, MD | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
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| Granisetron |
| Drug |
Granisetron 3mg d1-3 |
|
| Dexamethasone | Drug | Dexamethasone 10mg d1-3 |
|
| Cisplatin | Drug | 3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3 |
|
| up to 3 months |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077924 | Palonosetron |
| D017829 | Granisetron |
| D003907 | Dexamethasone |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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