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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multi-Centre Study to Compare Granulocyte-colony Stimulating Factors to Antibiotics for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induced Febrile Neutropenia REaCT-TC2

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 Summary:
Sponsor: Ottawa Hospital Research Institute

Current Primary Outcome:

  • Febrile neutropenia [ Time Frame: 2 years ]
    Number of participants with febrile neutropenia
  • Treatment-related hospitalization [ Time Frame: 2 years ]
    Number of participants admitted to hospital for treatment-related reasons


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Ottawa Hospital Research Institute

Dates:
Date Received: June 24, 2016
Date Started: September 2016
Date Completion: August 2019
Last Updated: September 27, 2016
Last Verified: September 2016