Ondansetron orodispersible film to prevent vomiting during pediatric radiotherapy
Efficacy and Safety of Ondansetron Orodispersible Film in Preventing Vomiting Induced by Moderately Emetogenic Risk Radiotherapy in Pediatric Patients With Malignant Tumors
This test tries whether a dissolvable ondansetron strip given once or twice can prevent vomiting in children aged 1–14 receiving moderate-emetic-risk radiotherapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Year to 14 Years |
| Sex | All |
| Sponsor | Chongqing University Cancer Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT07217600 on ClinicalTrials.gov |
What this trial studies
Children with malignant tumors who are scheduled for upper abdominal or craniospinal radiotherapy will receive ondansetron orodispersible film either once or twice during treatment to compare antiemetic effect and safety. The study enrolls patients aged 1–14 with adequate blood counts and liver tests and daily radiotherapy fractions (typically 1.8 Gy). Investigators will record vomiting episodes, rescue antiemetic use, and adverse events to determine which dosing schedule is most effective and well tolerated. The goal is to define a practical clinical dosing regimen for preventing radiation-induced vomiting in this pediatric population.
Who should consider this trial
Good fit: Ideal candidates are children aged 1–14 years with histologically confirmed malignant tumors, weight ≥8 kg, Lansky score ≥50, adequate blood counts and liver tests, and planned upper abdominal or craniospinal radiotherapy of moderate emetic risk.
Not a fit: Children outside the age/weight or laboratory criteria, those with severe liver dysfunction, very low blood counts, posterior fossa syndrome, or receiving radiotherapy fields not meeting the specified moderate emetic-risk criteria are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could reduce vomiting in children receiving radiotherapy, improving comfort and helping them complete treatment more easily.
How similar studies have performed: Ondansetron is an established antiemetic in children for chemotherapy and surgery, but use of the orodispersible film formulation specifically for pediatric radiotherapy-induced vomiting has been less studied.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Chongqing, Chongqing Municipality
- Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Yue Xie — Chongqing University Cancer Hospital, Chongqing, China
- Study coordinator: Yue Xie
- Email: 344899525@qq.com
- Phone: +86 13883080833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.