A Study to Compare Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Febrile Neutropenia

Phase 4

Completed

• Conditions: Early Stage Breast Cancer
• Interventions: Drug: Neupogen

• Registration Number: NCT02816164
• Lead Sponsor: Ottawa Hospital Research Institute

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-28
• Study Start: 2016-09
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

• Histologically confirmed primary breast cancer
• Planned to start docetaxel component of FEC-D or AC-D, or first cycle of; dose-dense AC-T, TC, FEC-D or TAC chemotherapy
• ≥19 years of age
• Able to provide verbal consent

Exclusion Criteria

• Contraindication to Filgrastim

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neupogen for 10 days	Neupogen	Neupogen injection for 10 days
Neupogen for 5 days	Neupogen	Neupogen injection for 5 days
Neupogen for 7 days	Neupogen	Neupogen injection for 7 days

Primary Outcome Measures

Name	Time	Method
Febrile neutropenia	2 years	Number of participants with febrile neutropenia
Treatment-related hospitalization	2 years	Number of participants admitted to emergency for treatment-related reasons

Secondary Outcome Measures

Name	Time	Method
Chemotherapy dose reduction	2 years	Number of participants who experience a dose reduction in their chemotherapy treatment
Chemotherapy discontinuation	2 years	Number of participants who stop chemotherapy for any reason
Chemotherapy dose delay	2 years	Number of participants who experience a dose delay with their chemotherapy treatment

Trial Locations

Locations (1)

The Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada