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Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Sponsor: Chinese University of Hong Kong
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.
Official title: Randomized Phase II Study of Personalized Antiemetic Regimen Based on Pharmacogenetic Profile for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients.
Key Details
Gender
FEMALE
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-03-31
Completion Date
2028-07-03
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
Standard antiemetic regimen or Olanzapine antiemetic regimen
Standard antiemetic regimen: * Day 1: Aprepitant 125mg QD (once daily); Ondansetron 8mg BD (twice daily); Dexamethasone 12mg QD (Aprepitant, Ondansetron and Dexamethasone to be take 60 minutes before chemotherapy on Day 1) * Days 2 to 3: Aprepitant 80mg QD Olanzapine antiemetic regimen: * Day 1: Aprepitant 125mg QD; Ondansetron 8mg BD; Dexamethasone 12 mg QD; Olanzapine 10mg QD (Aprepitant, Ondansetron and Dexamethasone to be take 60 minutes before chemotherapy on Day 1); Olanzapine 10mg nocte * Days 2 to 3: Aprepitant 80mg QD; Olanzapine 10mg nocte * Days 4-5: Olanzapine 10mg nocte
Standard antiemetic regimen
* Day 1: Aprepitant 125mg QD; Ondansetron 8mg BD; Dexamethasone 12mg QD (Aprepitant, Ondansetron and Dexamethasone to be take 60 minutes before chemotherapy on Day 1) * Days 2 to 3: Aprepitant 80mg QD
Locations (1)
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong