Ondansetron Orodispersible Film for Vomiting Prevention in Pediatric Radiotherapy

Sponsor
Chongqing University Cancer Hospital
Study ID
NCT07217600
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
1 Year - 14 Years
Healthy Volunteers
Not accepted

Interventions

  • Ondansetron orodispersible film once — DRUG
    Take ondansetron orodispersible film once 1-2 hours before each radiotherapy
  • Ondansetron orodispersible film twice — DRUG
    Take ondansetron orodispersible film once before each radiotherapy , and once again 8 hours after the first dose.

Study Details

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.

Key Dates

First listed
Oct 16, 2025
Start date
Mar 25, 2025
Status verified
Oct 2025
Primary completion
Mar 31, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: group QD
  • Active Comparator: group BID

Primary Outcome Measure

Efficacy in preventing vomiting between the two groups, as per 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 radiotherapy ]

Central Contacts

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