chemotherapy-
Conditions
Interventions
olanzapine 10 mg orally on day 1 before chemotherapy then 10 mg orally once daily on day 2,
and 4. ,Macthing placebo rally on day 1 before chemotherapy then 10 mg orally once daily on day 2,
and 4.
Experimental Drug,Placebo Comparator Drug
Onlanzapine 10 mg,Macthing placebo
Sponsors
Rajavithi Fondation
UL1 TR002377
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old or older 2. diagnosed histology confirmed early stage breast cancer, including invasive ductal and invasive lobular carcinoma. 3. cheduled to receive AC regimen (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2). 4. needed to have a European Cooperative Oncology Group (ECOG) performance status of 0 or 1 5.a serum creatinine level of 2.0 mg per deciliter or less 6. an aspartate or alanine aminotransferase level that was no more than 3 times the upper limit of the normal range 7. a hemoglobin level was 10 mg per deciliter or more, a white blood cell count was 3,000 cells per cubic millimeter or more 8. absolute neutrophil count was 1,500 cells per cubic millimeter or more.
Exclusion criteria
Exclusion criteria: 1.Patients who previously received chemotherapy 2. Pregnancy or lactation patients 3.The history of allergy to planned study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NO nausea the first 24 hours after chemotherapy administration daily records of episodes of vomiting or retching and use of rescue therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| A complete remission (no emetic episodes and no use of rescue medication) the first 24 hours after chemotherapy administration daily records of episodes of vomiting or retching and use of rescue therapy | — |
Countries
Thailand
Contacts
Public ContactPiyawan TIenchaiananda
Doctor Professional Level
Outcome results
None listed