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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02428114
Other study ID # OTT 14-05
Secondary ID
Status Completed
Phase N/A
First received April 15, 2015
Last updated September 27, 2017
Start date May 2015
Est. completion date March 2017

Study information

Verified date September 2017
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 142
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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


Locations

Country Name City State
Canada Cancer Centre of Southeastern Ontario at Kingston General Hospital Kingston Ontario
Canada The Ottawa Hospital Research Institute Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of performing this study will be measured with composite endpoints: physician engagement, time for local or provincial research ethics approval, accrual rates, and patient/physician compliance. 1 year
Secondary Rates of documented febrile neutropenia (laboratory confirmation) 1 year
Secondary ANC results at the end of each cycle of chemotherapy. 1 year
Secondary hospital admissions 1 year
Secondary percentage of patients who require chemotherapy dose delays 1 year
Secondary percentage of patients who require chemotherapy dose decrease 1 year
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