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| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR2400093665 | Registry Identifier | Chinese Clinical Trial Registry |
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The goal of this study is to evaluate the antiemetic efficacy and drug safety of ondansetron orodispersible film in pediatric patients with malignant tumors who received moderate emetic risk radiation induced vomiting, and to formulate reasonable and effective clinical medication regimen for preventing vomiting caused by moderate emetic risk radiation in children with malignant tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group QD | Experimental |
| |
| group BID | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron orodispersible film once | Drug | Take ondansetron orodispersible film once 1-2 hours before each radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy in preventing vomiting between the two groups, as per the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 | Vomiting was divided into 5 grades according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 | From the first day of radiotherapy to 7 days after the end of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reaction rate | From the first day of radiotherapy to 7 days after the end of radiotherapy | |
| The frequency of rescue treatments | Ratio of the number of rescue antiemetic uses to the number of radiotherapy fractions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue Xie | Contact | +86 13883080833 | 344899525@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yue Xie | Chongqing University Cancer Hospital, Chongqing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing University Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | China |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
The initial data are available on request from the project leaders(344899525@qq.com),upon reasonable request.
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Ondansetron orodispersible film twice | Drug | Take ondansetron orodispersible film once before each radiotherapy , and once again 8 hours after the first dose. |
|
| From the first day of radiotherapy to 7 days after the end of radiotherapy |