Health Condition 1: - Health Condition 2: - Health Condition 3: C50- Malignant neoplasm of breast
Conditions
Interventions
None listed
Sponsors
shalini verma
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with breast cancer and receiving Adriamycin and cyclophosphamide-based highly emetogenic chemotherapy; 2. Age > 18yrs ; 3. Patients had to be without nausea in the 24 hours prior to beginning chemotherapy; 4. Adequate Organ function -serum creatinine 1,500 mm3
Exclusion criteria
Exclusion criteria: 1. Patients who were on antiemetics other than palonosetron, dexamethasone, and olanzapine/aprepitant as an antiemetic prophylaxis regimen 2. Concurrent radiation therapy 3. Patients suffering from tumors with brain metastasis/ or with serious psychiatric conditions 4. Acutely ill patients such with serious liver and renal disorders and serious cardiac disorders with left ventricular ejection fraction 5. Pregnant and lactating women 6. History of chronic alcoholism. 7. Unable or refused to cooperate in the evaluation form of nausea and vomiting.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Rating of nausea and vomiting will be by using MAT tool/CTCAE version 5.0 2. The proportion of patients achieving Complete response (CR), Complete Control (CC), and Total control (TC) of CINV with different doses of olanzapine in different phases of emesis, will be assessed as: CR rate: no emetic episodes and no administration of rescue medication for CINV CC rate : CR+ no significant nausea (defined as no more than mild nausea) and ; TC rate: CC+ no nausea. Timepoint: one year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy assessment with Quality of life Questionnaire 2. Assessment of best-tolerated dose with least side effects Timepoint: one year | — |
Countries
India
Contacts
Public ContactShalini verma
kmc manipal, india
Outcome results
None listed