Efficacy and Safety of Ondansetron Orodispersible Film in Preventing Vomiting Induced by Moderately Emetogenic Risk Radiotherapy in Pediatric Patients With Malignant Tumors

NCT07217600 Phase 4 RECRUITING

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.

Details

Lead sponsor	Chongqing University Cancer Hospital
Phase	Phase 4
Status	RECRUITING
Enrolment	60
Start date	2025-03-25
Completion	2026-04

Conditions

• Radiotherapy-induced Nausea and Vomiting (RINV)
• Pediatric Cancer

Interventions

• Ondansetron orodispersible film once
• Ondansetron orodispersible film twice

Primary outcomes

• Efficacy in preventing vomiting between the two groups, as per 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
  Vomiting was divided into 5 grades according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0

Countries

China