REaCT Integrated Consent Model to Compare Two Standard of Care Regimens

NCT02173262 | Completed Phase 4 DMC

• 1 other identifier: 20140380-01H
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• rates of febrile neutropenia

  Once when the last participant completes chemotherapy up to year 2

Study Arms (2)

G-CSF

OTHER

Participants will receive a daily injection of G-CSF while on chemotherapy for prevention of febrile neutropenia.

Drug: G-CSF

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.

Drug: Ciprofloxacin

Interventions

G-CSF DRUG

Also known as: granulocyte-colony stimulating factor

G-CSF

Ciprofloxacin DRUG

Also known as: Cipro, Cipro XR, Proquin XR

Ciprofloxacin

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Contraindication to either Ciprofloxacin or G-CSF

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

• 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.

  PMID: 30099602 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Granulocyte Colony-Stimulating Factor; Ciprofloxacin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mark Clemons, Doctor

  The Ottawa Hospital Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 24, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-10

Locations

CA (1)