Ondansetron Orodispersible Film for Vomiting Prevention in Pediatric Radiotherapy
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Children with malignant tumors diagnosed by histopathology * Age range: 1-14 years old (calculated from the day of signing the informed consent form) * Weight \>= 8Kg; * Lansky functional status (LPS) score \>= 50 (excluding posterior fossa syndrome) * Be planned to undergo upper abdominal or craniospinal radiation therapy, and the upper abdominal irradiation should cover the anatomical area from the upper edge of the 11th thoracic vertebra to the lower edge of the third lumbar vertebra * Radiotherapy is administered once daily, and the fractional dose is 1.8Gy, except for 1.5 Gy for whole abdominal radiotherapy * The blood routine test must meet the following criteria: ANC \>= 1.0 × 10\^9/L (after discontinuation of G-CSF), PLT \>= 50 × 10\^9/L (without drug support or transfusion therapy), HGB \>= 80g/L * Biochemical tests must meet the following standards: total bilirubin \<= 1.5 times ULN (upper limit of normal), ALT \<= 2.5 times ULN, AST \<= 2.5 times ULN, a