drugset / Trial / NCT04912271

Granisetron Transdermal Patch for Prophylaxis of Delayed CINV

NCT04912271

Phase 3 Unknown 140 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

Transdermal granisetron has been shown to as effective as oral/ intravenous granisetron when administered with or without dexamethasone. However, it has not been evaluated specifically against the delayed response of chemotherapy-induced nausea and vomiting (CINV) in comparison with palonosetron, as the complete response for the delayed phase was not reported in the comparative study by Seol et al (Support Care Cancer 2016;24:945-952). Thus, transdermal granisetron needs to be compared with palonosetron as part of dual and triple therapy in the delayed phase of CINV. This investigator-initiated study aims to compare the efficacy of granisetron transdermal patch and palonosetron combined with NK-1 receptor antagonist and dexamethasone in the prevention of delayed CINV in Chinese breast cancer patients who received high emetic or moderate emetic chemotherapy.

Timeline

Start
2021-06-10
Primary completion
2022-06-10
Completion
2023-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Granisetron Other / unclassified Other
Comparator Palonosetron Other / unclassified 0.25 mg Intravenous
Background Aprepitant Other / unclassified 80 mg Oral
Background Dexamethasone Small molecule 7.5 mg Intravenous
Background Dexamethasone Small molecule 10 mg Intravenous
Background Fosaprepitant Other / unclassified 150 mg Intravenous