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REaCT Integrated Consent Model to Compare Two Standard of Care Regimens (OTT14-03)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02173262
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
The Integrated Consent Model is being increasingly used internationally to improve patient care. In this feasibility study we will explore whether the model is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials, and address the critical issue around the optimal febrile neutropenia prevention by randomizing eligible patients to either G-CSF or ciprofloxacin.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: G-CSF Drug: Ciprofloxacin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
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

Arm Intervention/treatment
Participants will receive a daily injection of G-CSF while on chemotherapy for prevention of febrile neutropenia.
Drug: G-CSF
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.
Drug: Ciprofloxacin
Other Names:
  • Cipro
  • Cipro XR
  • Proquin XR

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed primary breast cancer
  • Planned TC chemotherapy
  • ≥19 years of age
  • Able to provide verbal consent
  • Willing to complete a survey

Exclusion Criteria:

• Contraindication to either Ciprofloxacin or G-CSF

Information from the National Library of Medicine

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 identifier (NCT number): NCT02173262

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Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
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Principal Investigator: Mark Clemons, Doctor The Ottawa Hospital Cancer Centre
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ottawa Hospital Research Institute Identifier: NCT02173262    
Other Study ID Numbers: 20140380-01H
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Keywords provided by Ottawa Hospital Research Institute:
Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors