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Completed

NCT Number: NCT02816164

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neupogen

Drug

Subcutaneous injections

Other names: Filgrastim

Primary outcomes

  1. Febrile neutropenia

    Time frame: 2 years

    Number of participants with febrile neutropenia

  2. Treatment-related hospitalization

    Time frame: 2 years

    Number of participants admitted to emergency for treatment-related reasons

Secondary outcomes

  1. Chemotherapy dose delay

    Time frame: 2 years

    Number of participants who experience a dose delay with their chemotherapy treatment

  2. Chemotherapy dose reduction

    Time frame: 2 years

    Number of participants who experience a dose reduction in their chemotherapy treatment

  3. Chemotherapy discontinuation

    Time frame: 2 years

    Number of participants who stop chemotherapy for any reason

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study 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 Cancer (REaCT-G2)

Acronym: REaCT-G2

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2016
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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