Ondansetron Orodispersible Film for Vomiting Prevention in Pediatric Radiotherapy
Recruiting
Phase 4Interventional 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.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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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