Comparative Study on the Efficacy and Safety of Ondansetron Oral Membrane for the Prevention of Vomiting During Moderate Hypoemetic Chemotherapy

Launched by SHANGHAI CHILDREN'S MEDICAL CENTER · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different forms of a medication called ondansetron, which is used to prevent vomiting in children receiving certain types of chemotherapy. Specifically, the study compares an ondansetron mouth soluble film to an ondansetron tablet in children aged 4 to 15 years who are about to start moderate or low-emetic chemotherapy (types of chemotherapy that can cause vomiting). The main goal is to see which form of the medication works better in keeping children from vomiting in the first 24 hours after their chemotherapy treatment.

To participate in this trial, children must be diagnosed with a malignant tumor and need to receive chemotherapy. They should be able to tolerate the treatment, have a life expectancy of at least 3 months, and their families must be willing to keep track of any vomiting. However, children with certain conditions, such as allergies to similar medications or active infections, will not be eligible to join. Participants will receive either the mouth film or the tablet along with another medication called dexamethasone, and they will be monitored for any vomiting for a period after their chemotherapy. This study aims to ensure that children can receive their treatments with less discomfort and better outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged 4 to 15 years who have been diagnosed with malignant tumor through pathological examination and need to receive chemotherapy, gender is not limited;
• • Receive moderate and low grade emetic chemotherapy;
• • Patients with a score greater than 60 or higher have a life expectancy greater than 3 months;
• • The patients were enrolled voluntarily, and the family members signed the informed consent, and the family members had good compliance and accurately recorded the vomiting diary.
• Exclusion Criteria:
• • Children allergic to 5HT3 antagonists;
• • Active infection;
• • Abnormal bone marrow function (absolute neutrophil count \<1000/mm3 platelet count \<100000/mm3);
• • Abnormal renal function in serum creatinine beyond the upper age limit of normal (ULN);
• • Abnormal liver function of serum aspartate aminotransferase and alanine aminotransferase, age and serum bilirubin are 1.5 times that of ULN;
• • vomiting 24 hours before chemotherapy begins;
• • Start systemic corticosteroid therapy within 72 hours prior to study drug use, or plan to receive corticosteroids as part of a chemotherapy regimen;
• • Patients with benzodiazepines or opioids