New oral film could stop radiation sickness in kids with cancer
NCT ID NCT07217600
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a dissolvable film containing ondansetron to prevent vomiting caused by radiation therapy in children aged 1-14 with cancer. The film is placed on the tongue and melts without water. Researchers will compare its effectiveness and safety against standard care in 60 children receiving moderate-risk radiation to the upper abdomen or spine.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 14 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 upper abdominal or craniospinal radiation therapy, and the upper abdominal irradiation should cover the anatomical area from the upper edge of the 11th thoracic vertebra to the lower edge of the third lumbar vertebra * Radiotherapy is administered once daily, and the fractional dose is 1.8Gy, except for 1.5 Gy for whole abdominal radiotherapy * The blood routine test must meet the following criteria: ANC \>= 1.0 × 10\^9/L (after discontinuation of G-CSF), PLT \>= 50 × 10\^9/L (without drug support or transfusion therapy), HGB \>= 80g/L * Biochemical tests must meet the following standards: total bilirubin \<= 1.5 times ULN (upper limit of normal), ALT \<= 2.5 times ULN, AST \<= 2.5 times ULN, alkaline phosphatase ≤ 1.5 times ULN, serum albumin \>= 2.5 g/dL, BUN and CRE \<= 1.5 × ULN * Expected survival period \>= 3 months; * The guardian of the child understands and signs the informed consent form, has good compliance, and cooperates with follow-up. Exclusion Criteria: * 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 * Joint use of apomorphine * Congenital QT prolongation syndrome * Severe gastrointestinal obstruction * Other observers who affect the efficacy and adverse reactions * Used other 5-HT3 receptor antagonists in the first 3 days of enrollment * According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the safety of the subjects or the collection of experimental data.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chongqing University Cancer Hospital
RECRUITINGChongqing, Chongqing Municipality, China
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