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

This study is currently recruiting participants.
Verified September 2016 by Ottawa Hospital Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02173262
First Posted: June 24, 2014
Last Update Posted: September 16, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
  Purpose
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 Intervention
Breast Cancer Drug: G-CSF Drug: Ciprofloxacin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 35
Study Start Date: August 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
G-CSF
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
Ciprofloxacin
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02173262


Contacts
Contact: Mark Clemons, Doctor 613-737-7720 ext 70170 mclemons@toh.on.ca

Locations
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Mark Clemons, FRCP(UK)    613-737-7700 ext 70170    mclemons@toh.on.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Mark Clemons, Doctor The Ottawa Hospital Cancer Centre
  More Information

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02173262     History of Changes
Other Study ID Numbers: 20140380-01H
First Submitted: June 16, 2014
First Posted: June 24, 2014
Last Update Posted: September 16, 2016
Last Verified: September 2016

Keywords provided by Ottawa Hospital Research Institute:
Breast

Additional relevant MeSH terms:
Ciprofloxacin
Lenograstim
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
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs