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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-CSF | Other | Participants will receive a daily injection of G-CSF while on chemotherapy for prevention of febrile neutropenia. |
|
| Ciprofloxacin | Other | Participants will receive Ciprofloxacin 500 mg twice a day by mouth for 10 days of each cycle during chemotherapy for prevention of febrile neutropenia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-CSF | Drug |
|
| |
| Ciprofloxacin |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of randomized patients in each physician's practice | 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. | every 4 weeks up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| rates of febrile neutropenia | Rates of febrile neutropenia will be compared between Ciprofloxacin and G-CSF | Once when the last participant completes chemotherapy up to year 2 |
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Inclusion Criteria:
Exclusion Criteria:
• Contraindication to either Ciprofloxacin or G-CSF
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| Name | Affiliation | Role |
|---|---|---|
| Mark Clemons, Doctor | The Ottawa Hospital Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30099602 | Derived | Clemons M, Mazzarello S, Hilton J, Joy A, Price-Hiller J, Zhu X, Verma S, Kehoe A, Ibrahim MF, Sienkiewicz M, Stober C, Vandermeer L, Hutton B, Mallick R, Fergusson D. Feasibility of using a pragmatic trials model to compare two primary febrile neutropenia prophylaxis regimens (ciprofloxacin versus G-CSF) in patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer (REaCT-TC). Support Care Cancer. 2019 Apr;27(4):1345-1354. doi: 10.1007/s00520-018-4408-6. Epub 2018 Aug 11. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 25, 2022 | |
| Reset | Sep 28, 2023 | |
| Release | Apr 11, 2025 | |
| Reset | May 2, 2025 | |
| Release | Aug 18, 2025 | |
| Reset | Sep 8, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 25, 2022 | Sep 28, 2023 | |||
| Apr 11, 2025 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Drug |
|
|
| May 2, 2025 |
| Aug 18, 2025 | Sep 8, 2025 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |