Actively Recruiting
Ondansetron Orodispersible Film for Vomiting Prevention in Pediatric Radiotherapy
Led by Chongqing University Cancer Hospital · Updated on 2025-10-20
60
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ondansetron Orodispersible Film for Vomiting Prevention in Pediatric Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children diagnosed with malignant tumors by histopathology
- Age between 1 and 14 years old as of signing consent
- Weight at least 8 kilograms
- Lansky functional status (LPS) score of 50 or higher (excluding posterior fossa syndrome)
- Planned to undergo upper abdominal or craniospinal radiation therapy covering specific anatomical areas
- Radiotherapy given once daily with fractional dose 1.8 Gy (1.5 Gy for whole abdominal radiotherapy)
- Blood tests meeting ANC ≥ 1.0 × 10^9/L, PLT ≥ 50 × 10^9/L without drug support or transfusion, and HGB ≥ 80 g/L
- Biochemical tests within limits: total bilirubin ≤ 1.5 × ULN, ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, alkaline phosphatase ≤ 1.5 × ULN, serum albumin ≥ 2.5 g/dL, BUN and CRE ≤ 1.5 × ULN
- Expected survival period of 3 months or more
- Guardian understands and signs informed consent and cooperates with follow-up
You will not qualify if you...
- Nausea and vomiting from surgery not fully recovered if major surgery occurred
- Symptoms of central nervous system tumors such as cerebral edema requiring adrenal cortex hormone intervention
- Participation in other clinical studies within 4 weeks prior to first investigational drug use
- Allergy to 5-HT3 receptor antagonists or other excipients
- Concurrent use of apomorphine
- Congenital QT prolongation syndrome
- Severe gastrointestinal obstruction
- Factors affecting efficacy or adverse reactions
- Use of other 5-HT3 receptor antagonists within first 3 days of enrollment
- Other serious illnesses, severe lab abnormalities, or family/social factors that may affect safety or data collection as assessed by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
Research Team
Y
Yue Xie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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