Ondansetron Orodispersible Film for Vomiting Prevention in Pediatric Radiotherapy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-14
SponsorChongqing University Cancer Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
The nausea and vomiting caused by the surgery have not fully recovered if the subject has undergone a major surgery
The patient has symptoms of central nervous system tumors such as cerebral edema and requires intervention with adrenal cortex hormones
Participants who have participated in or are currently participating in other clinical studies within 4 weeks prior to the first use of the investigational drug (calculated based on the time of the last use of the investigational drug for those who have entered the follow-up period)
Individuals allergic to 5-HT3 receptor antagonists or other excipients
Trial design
Design model
Parallel
Treatments tested in this trial
Ondansetron orodispersible film once
DrugTake ondansetron orodispersible film once 1-2 hours before each radiotherapy
Ondansetron orodispersible film twice
DrugTake ondansetron orodispersible film once before each radiotherapy , and once again 8 hours after the first dose.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: group QDExperimental treatment 1 intervention
Group B: group BIDActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From the first day of radiotherapy to 7 days after the end of radiotherapySecondary outcomes
1
Adverse reaction rate
Time frame
From the first day of radiotherapy to 7 days after the end of radiotherapy2
The frequency of rescue treatments
Ratio of the number of rescue antiemetic uses to the number of radiotherapy fractions
Time frame
From the first day of radiotherapy to 7 days after the end of radiotherapySponsors and contacts
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Source ClinicalTrials.gov