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

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Drug: G-CSF; Drug: Ciprofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02173262

20140380-01H

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

G-CSF

Other group

Description:

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

Treatment:

Drug: G-CSF

Ciprofloxacin

Other group

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.

Treatment:

Drug: Ciprofloxacin