REaCT Integrated Consent Model to Compare Two Standard of Care Regimens (OTT14-03)
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|ClinicalTrials.gov Identifier: NCT02173262|
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: G-CSF Drug: Ciprofloxacin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induces Febrile Neutropenia|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
Participants will receive a daily injection of G-CSF while on chemotherapy for prevention of febrile neutropenia.
Other Name: granulocyte-colony stimulating factor
Participants will receive Ciprofloxacin 500 mg twice a day by mouth for 10 days of each cycle during chemotherapy for prevention of febrile neutropenia.
- The percentage of randomized patients in each physician's practice [ Time Frame: every 4 weeks up to 2 years ]The percentage of randomized patients will be measured by collecting reasons for NOT complying with, or "opting-out" of the randomized selection compared to the overall accrual.
- rates of febrile neutropenia [ Time Frame: Once when the last participant completes chemotherapy up to year 2 ]Rates of febrile neutropenia will be compared between Ciprofloxacin and G-CSF
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173262
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||Mark Clemons, Doctor||The Ottawa Hospital Cancer Centre|