Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia

Phase 4

Completed

• Conditions: Early Stage Breast Cancer
• Interventions: Drug: Ciprofloxacin; Drug: Neupogen

• Registration Number: NCT02816112
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

Taxotere-cyclophosphamide (TC) chemotherapy is commonly used as an adjuvant chemotherapy regimen in patients with resected early stage breast cancer. TC chemotherapy can cause febrile neutropenia (FN) which can be serious and associated with treatment delays and dose reductions, thereby compromising treatment efficacy. To reduce the risk of chemotherapy-induced FN,TC is administered with either one of two highly effective standard treatments; namely primary prophylaxis with either ciprofloxacin or granulocyte colony-stimulating factor (G-CSF). However, there are considerable cost differences between these strategies; subcutaneous daily G-CSF costs at least $12,000 over 4 cycles of treatment while oral ciprofloxacin costs about $100.

The investigators have therefore been performing a feasibility study to explore whether the "integrated consent model" involving oral consent is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials. This feasibility study (REaCT-TC NCT02173262) has been an amazing success and the investigators are therefore now performing a definitive study comparing G-CSF with ciprofloxacin. This study will not be evaluating feasibility endpoints, but rather clinically important endpoints of hospitalizations and febrile neutropenia rates.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-28
• Study Start: 2016-09
• Primary Completion: 2020-03
• Study Completion: 2020-04
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 458

Inclusion Criteria

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

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Exclusion Criteria

• Contraindication to either Ciprofloxacin or G-CSF

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciprofloxacin	Ciprofloxacin	Oral tablet taken twice a day at home starting 5 days after chemotherapy for 14 days for every cycle of TC
G-CSF	Neupogen	Daily injection at home for the number of days as chosen by the treating physician

Primary Outcome Measures

Name	Time	Method
Treatment-related hospitalization	2 years	Number of participants admitted to hospital for treatment-related reasons
Febrile neutropenia	2 years	Number of participants with febrile neutropenia

Secondary Outcome Measures

Name	Time	Method
Chemotherapy dose reduction	2 years	Number of participants who receive a dose reduction of their TC chemotherapy
Microbiologic infections	2 years	Number of participants who have a microbiologic infection (i.e: Clostridium difficile)
Chemotherapy dose delay	2 years	Number of participants who receive a dose delay in their TC chemotherapy
Chemotherapy discontinuation	2 years	Number of participants who stop TC chemotherapy for any reason

Trial Locations

Locations (1)

The Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada