Clinical Trial: A Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Febrile Neutropenia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multi Centre Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Ca
Brief Summary: In patients with early-stage breast cancer, chemotherapy has substantially improved survival rates. Improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, the most notable being neutropenia. Neutropenia is the presence of abnormally few white blood cells, leading to increase susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal. Febrile neutropenia (FN) can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy. Patients can receive medication to reduce the risk of FN such as Neupogen (filgrastim) as a daily injection for 5, 7 or 10 days. Since there is genuine uncertainty among healthcare professionals as to which administration schedule of Neupogen is the best for patients, the investigators are performing a randomized study for which patients will receive either 5, 7 or 10 days of Neupogen. Neupogen can cost approximately $200/injection, so if a physician prescribes 10 days for 8 cycles of treatment, this can cost $16,000 compared to a 5 day treatment 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 oral consent model to compare 5, 7 and 10 days of Neupogen to evaluate rates of febrile neutropenia and hospitalization.
Detailed Summary:
Sponsor: Ottawa Hospital Research Institute
Current Primary Outcome:
- Febrile neutropenia [ Time Frame: 2 years ]Number of participants with febrile neutropenia
- Treatment-related hospitalization [ Time Frame: 2 years ]Number of participants admitted to emergency for treatment-related reasons
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Chemotherapy dose delay [ Time Frame: 2 years ]Number of participants who experience a dose delay with their chemotherapy treatment
- Chemotherapy dose reduction [ Time Frame: 2 years ]Number of participants who experience a dose reduction in their chemotherapy treatment
- Chemotherapy discontinuation [ Time Frame: 2 years ]Number of participants who stop chemotherapy for any reason
Original Secondary Outcome: Same as current
Information By: Ottawa Hospital Research Institute
Dates:
Date Received: June 24, 2016
Date Started: September 2016
Date Completion: December 2019
Last Updated: September 27, 2016
Last Verified: September 2016