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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
200
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
* 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
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
RECRUITINGComplete Protection (CP)
CP was defined as no vomiting, no use of rescue therapy and 'no significant nausea' (NSN) during the study periods. NSN is defined as a nausea VAS of \<25 mm.
Time frame: 2 years
No Nausea (NN)
NN is defined as a nausea VAS of \<5 mm.
Time frame: 2 years
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