A Randomized, Phase IV Trial of Individualized Care Versus Standard Care, in the Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients. The EPIC Study
A Randomized, Phase IV Trial of Individualized Care Versus Standard Care, in the Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients. The EPIC Study
For breast cancer patients receiving chemotherapy regimens, the use of a validated emesis (nausea and vomiting) risk calculator will provide superior anti-emetic (nausea and vomiting) control compared with "standard" anti-emetic regimen. The risk calculator has the potential to provide more individualized anti-emetic regimen by decreasing the use of toxic/costly anti-emetics in patients at low risk and possibly more importantly enhancing the appropriate anti-emetic regimen in patients at high risk.
Inclusion Criteria:
Newly diagnosed invasive breast cancer (stage I-III)
Scheduled to receive neoadjuvant or adjuvant intravenous anthracycline with cyclophosphamide-based chemotherapy;
Able to consent and fill study forms
Exclusion Criteria:
Received previous chemotherapy
Symptoms of nausea or vomiting at baseline (disease related)
On chronic anti-emetic therapy
On daily corticosteroids prior to initiation of chemotherapy
Allergic to steroids, 5HT3 or NK-1
Uncontrolled diabetes
Medical or psychiatric illness that would interfere with patients' ability to complete the diary