drugset / Trial / NCT05872893

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

NCT05872893

Phase 3 Completed 28 enrolled Immune Oncology Research Institute
RandomizedCrossoverSingle-blindSupportive care

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, the investigators suggest a continuous infusion of the above-mentioned drug combination as an alternative with potential superior activity.

Timeline

Start
2023-06-27
Primary completion
2025-01-30
Completion
2025-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 4 mg/m2
Subject Ondansetron Other / unclassified 5 mg/m2