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)

NCT ID: NCT02428114

Last Updated: 2017-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 142 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-03-31

Brief Summary

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.

Conditions

Early Stage Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

5 days of filgrastim

Standard of care

No interventions assigned to this group

7 days of filgrastim

Standard of care

No interventions assigned to this group

10 days of filgrastim

Standard of care

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Clemons, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, Canada

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Countries

Canada

References

Clemons M, Fergusson D, Simos D, Mates M, Robinson A, Califaretti N, Zibdawi L, Bahl M, Raphael J, Ibrahim MFK, Fernandes R, Pitre L, Aseyev O, Stober C, Vandermeer L, Saunders D, Hutton B, Mallick R, Pond GR, Awan A, Hilton J. A multicentre, randomised trial comparing schedules of G-CSF (filgrastim) administration for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer. Ann Oncol. 2020 Jul;31(7):951-957. doi: 10.1016/j.annonc.2020.04.005. Epub 2020 Apr 20.

Reference Type: DERIVED

PMID: 32325257 (View on PubMed)

Ibrahim MFK, Hilton J, Mazzarello S, Fergusson D, Hutton B, Robinson A, Califaretti N, Hsu T, Gertler S, Mates M, Stober C, Vandermeer L, Mallick R, Clemons M. A multi-center pragmatic, randomized, feasibility trial comparing standard of care schedules of filgrastim administration for primary febrile neutropenia prophylaxis in early-stage breast cancer. Breast Cancer Res Treat. 2018 Apr;168(2):371-379. doi: 10.1007/s10549-017-4604-y. Epub 2017 Dec 6.

Reference Type: DERIVED

PMID: 29214415 (View on PubMed)

Other Identifiers

OTT 14-05

Identifier Type: -

Identifier Source: org_study_id