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Prevention study for Radiotherapy-induced Nausea and Vomiting (RINV)
Official title Ondansetron Orodispersible Film for Vomiting Prevention in Pediatric Radiotherapy
ClinicalTrials.gov ID: NCT07217600
What this study is testing
What is Ondansetron orodispersible film once?
Ondansetron orodispersible film once is an investigational medicine, being studied as a potential treatment for radiotherapy-induced nausea and vomiting (rinv).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 14
You may be able to join if
- 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...
You likely can't join if
- 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...
- Individuals allergic to 5-HT3 receptor antagonists or other excipients
- Joint use of apomorphine
- Congenital QT prolongation syndrome
See the full eligibility 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...
- 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 \ = 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.
- 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...
- 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 how well it works 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 people to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require...
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.