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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PG arm | Experimental | In PG arms, there are 4 PG subgroups:
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| Non-PG arm | Experimental | Standard antiemetic regimen will be given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard antiemetic regimen or Olanzapine antiemetic regimen | Drug | Standard antiemetic regimen:
Olanzapine antiemetic regimen:
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| Measure | Description | Time Frame |
|---|---|---|
| Complete 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| No Nausea (NN) | NN is defined as a nausea VAS of <5 mm. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Winnie YEO, MBBS, MD, FRCP | Contact | 3505 1042 | winnie@clo.cuhk.edu.hk | |
| Dong LAI, RN | Contact | 3505 1138 | dong@clo.cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Oncology, Prince of Wales Hospital | Recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Standard antiemetic regimen | Drug |
|
|
| D017437 |
| Skin and Connective Tissue Diseases |