drugset / Trial / NCT07455955

Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile

NCT07455955

Phase 2 Recruiting 200 enrolled Chinese University of Hong Kong
RandomizedParallel-groupSingle-blindPrevention

Summary

The objectives of this study are to determine if pharmacogenetic (PG) analysis of an individual enable optimal selection of antiemetic regimen for patients undergoing the first cycle of AC (Adriamycin + Cyclophosphamide) or FEC (Fluorouracil + Epirubicin + Cyclophosphamide) chemotherapy. It also aims to compare the quality of life of patients in the first cycle of AC / FEC chemotherapy with and without PG analysis. Patients will be randomized to undergo PG analysis \[PG group\] versus no PG analysis \[Non-/+PG group\]. Those in the PG group would be offered currently available optimal antiemetic prophylaxis, with or without Olanzapine according to PG outcomes. Those in the Non-PG group would be offered currently available optimal antiemetic prophylaxis.

Timeline

Start
2026-03-31
Primary completion
2027-06-03
Completion
2028-07-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Olanzapine Small molecule 10 mg
Background Aprepitant Other / unclassified 80 mg
Background Dexamethasone Small molecule 12 mg
Background Ondansetron Other / unclassified 8 mg

Indications