Clinical trial · Interventional
REaCT Integrated Consent Model to Compare Two Standard of Care Regimens
Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induces Febrile Neutropenia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ciprofloxacin | Drug | — | UNRESOLVED |
| G-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- G-CSF
- description
- Participants will receive a daily injection of G-CSF while on chemotherapy for prevention of febrile neutropenia.
- interventionNames
- Drug: G-CSF
- type
- OTHER
- label
- Ciprofloxacin
- description
- Participants will receive Ciprofloxacin 500 mg twice a day by mouth for 10 days of each cycle during chemotherapy for prevention of febrile neutropenia.
- interventionNames
- Drug: Ciprofloxacin
Primary outcomes (1)
- measure
- The percentage of randomized patients in each physician's practice
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDClemons 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. PMID 30099602