Chemotherapy-induced Nausea and Vomiting Clinical Trial
Official title:
FORESIGHT: Feasibility of Olanzapine at REduced doSe in hIGHly Emetogenic chemoTherapy: a Randomised Controlled Trial Against Aprepitant in Triple Therapy
Olanzapine is frequently used off-label as an adjunct antiemetic in clinical oncology
settings. North American oncology guidelines recommend it as salvage therapy and as add-on to
the standard triple regimen; some suggest it may also be effective as an initial triple
therapy (olanzapine replacing the NK-1 antagonist) based on phase II and III trials.
This prospective, multi-center, open-label study aims to evaluate the feasibility of a large
scale randomised controlled trial to compare the effectiveness and tolerability of 5mg orally
once daily olanzapine in triple antiemetic therapy versus the standard treatment of
aprepitant + ondansetron + dexamethasone in treatment-naive patients receiving the first
cycle of a highly emetogenic chemotherapy. Secondary outcomes include effectiveness,
tolerability and quality of life assessments. Effectiveness will be measured with complete
response and complete remission rates in each treatment arms. Tolerability and patient
quality of life will be evaluated with a standardised side effect form and validated
questionnaires; ESAS-R and FLIE.
The role of olanzapine-based triple therapy in prevention of chemotherapy-induced nausea and
vomiting remains founded on low-quality evidence. To the investigator's knowledge, this study
will be the first large scale direct comparison of 5mg olanzapine versus aprepitant in triple
therapy.
n/a
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