Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Chemotherapy-induced nausea and vomiting are serious side effects of cancer treatment that can have a significant negative impact on a patient's quality of life. Although the prevalence of nausea and vomiting has significantly decreased due to the implementation of new antiemetic drugs, several studies revealed that approximately 30% to 60% of patients still complain of acute or delayed chemotherapy-induced emesis. It is estimated that slow infusion of ondansetron in combination with dexamethasone can provide long-lasting stable concentrations of drugs in the blood serum contributing to better effect development. Therefore, we suggest a continuous infusion of the above-mentioned drug combination as an alternative with potential superior activity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immune Oncology Research Institute
• Treatments: Dexamethasone; Ondansetron

Criteria

Inclusion Criteria:

• Patients aged from 1 day to 18 years who are diagnosed with cancer and are eligible for chemotherapy.

• Voluntarily agree to participate by giving written parental permission and child assent.

• Patients with sufficient cardiac function, as determined by the investigator.

Exclusion Criteria:

• Patients with a history of severe hypersensitivity reactions or anaphylaxis related to the use of 5-HT3 receptor antagonists.

• Patients receiving concurrent chemo-radiation therapy.

• Patients diagnosed with cardiac arrhythmias and congenital long QT interval syndrome.

• Known clinically significant drug interactions between chemotherapeutic agents and 5-HT3 receptor antagonists and/or Dexamethasone (e.g. more than 0.8 mg/ml concentrations of 5-fluorouracil may cause precipitation of ondansetron).