Ondansetron Film for Vomiting in Pediatric Cancer

Ondansetron Orodispersible Film for Vomiting Prevention in Pediatric Radiotherapy

Recruiting Phase 4 Interventional Study
Radiotherapy-induced Nausea and Vomiting (RINV) Pediatric Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
1 – 14
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Prevention
Participants needed
60 (estimated)
Sponsor
Chongqing University Cancer Hospital · Other
Who this trial is looking for

This trial is looking for children aged 1-14 with cancer who will receive certain types of radiation therapy. Participation involves taking ondansetron orodispersible film to help prevent vomiting caused by the treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have a malignant tumor diagnosed by a doctor.
  • I am between 1 and 14 years old.
  • I weigh at least 8 kg.
  • I am scheduled to have upper abdominal or craniospinal radiation therapy.
  • I have a Lansky performance status score of 50 or more.
  • I expect to survive for at least 3 months.
  • My guardian understands and signs the consent form.

You may not be able to join if

  • I have not fully recovered from nausea and vomiting caused by recent major surgery.
  • I have symptoms of central nervous system tumors that need hormone treatment.
  • I have participated in other clinical studies in the past 4 weeks.
  • I am allergic to 5-HT3 receptor antagonists or other ingredients.
  • I have congenital QT prolongation syndrome.
  • I have severe gastrointestinal obstruction.
  • I used other 5-HT3 receptor antagonists in the last 3 days.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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.

Trial Locations
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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 up…
Contacts

Yue Xie

+86 13883080833

344899525@qq.com

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