A Multi Centre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Standard of Care Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (React-G Study)
In patients with early-stage breast cancer, chemotherapy has substantially improved survival
rates for breast cancer patients. Improvements in outcomes, however, are compromised by the
considerable toxicities associated with chemotherapy, most notable being neutropenia.
Neutropenia is the presence of abnormally few white blood cells, leading to increased
susceptibility to infection and can require hospitalization and need for intravenous
antibiotics and is sometimes fatal. Febrile neutropenia can also be associated with
treatment delays and dose reductions, potentially compromising treatment efficacy. Patients
can receive medication to reduce the risk of febrile neutropenia, such as Neupogen
(Filgrastim) as a daily injection for 5, 7, or 10 days. Since there is genuine uncertainty
amongst healthcare professionals as to which administration schedule of Neupogen is better,
investigators are performing a randomized study in which patients are put into a group by
chance to give participants one of three standards of Neupogen daily injection. Neupogen can
cost approximately $200 per injection, so if a physician prescribes 10 days for 8 cycles of
treatment this can cost $16,000 compared to a 5 day prescription which would cost half this.
In addition to cost savings, many patients are not able to give themselves injections on a
daily basis and require nursing resources which are utilized at high-cost. This study will
use an "integrated consent model" that involves an "oral consent" rather than a written
informed consenting process in order to increase the number of patients who may participate
while performing a study at a lower cost. While determining the optimal treatment will
improve patient comfort and acceptability, using the minimal safe duration of administration
may also offer cost savings.
View this trial on ClinicalTrials.gov
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