Breast Cancer Clinical Trial
Official title:
A Randomized Trial of Individualised Care Versus Standard Care for Breast Cancer Patients at High Risk for Chemotherapy Induced Nausea and Vomiting. The ILIAD Study
The purpose of this study is to evaluate whether adding olanzapine 5mg to standard antiemetic
medication can significantly reduce chemotherapy-induced nausea and vomiting in breast cancer
patients receiving emetogenic chemotherapy regimens such as anthracycline with
cyclophosphamide-based chemotherapy and platinum-based chemotherapy.
To help clinicians prescribe antiemetic medications in a more patient-centered,
evidence-based and cost-effective manner, we've developed the world's first validated
risk-stratification tool for chemotherapy-induced nausea and vomiting (CINV) and because of
this, it is now possible to perform a trial of personalized precision antiemetic therapy for
breast cancer patients.
Despite widespread antiemetic use, chemotherapy-induced nausea and vomiting (CINV) remains
among the most feared and expected side effects of chemotherapy for breast cancer.
Inadequately controlled CINV can significantly reduce a patient's quality of life, impair
functional activity, lead to chemotherapy dose delays and reductions, and even
discontinuation of treatment. The merit of current antiemetic medications is based on their
ability to control chemotherapy-induced vomiting, but not necessarily nausea, and nausea is
the major issue for breast cancer patients.
With olanzapine demonstrating significant promise in preventing acute and delayed nausea, the
investigators are proposing to evaluate guideline-recommended aprepitant-based triple regimen
compared to the same regimen plus olanzapine (5 mg) for patients at high personal risk for
CINV. For patients at low personal risk for CINV the investigators will also evaluate
guideline-recommended double antiemetic regimen compared to the same regimen plus olanzapine
(5 mg).
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