Status:
UNKNOWN
Iron Supplement in the Prevention of Anemia in Female Breast Cancer Patients
Lead Sponsor:
Instituto do Cancer do Estado de São Paulo
Collaborating Sponsors:
Fundação Faculdade de Medicina
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Study to evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens.
Eligibility Criteria
Inclusion
- Women older than 18 years
- Patient with operated breast cancer with indication for (NEO)adjuvant therapy
- They must have hemoglobin levels within the normal range (\> 12g/dL), absence of renal and hepatic dysfunction as assessed by serum levels of urea, creatinine, AST, ALT.
- Lack of folic acid deficiency and vitamin B12
- Able to provide written informed consent.
Exclusion
- Use of any oral supplement containing iron;
- Patients who have iron overload as defined by serum ferritin\> 800 microg / L or transferrin saturation\> 40%;
- Patients who are pregnant or breastfeeding;
- History of active infection or active bleeding except menstruation;
- History of HIV or hepatitis B or C - clinically important; -
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01168505
Start Date
May 1 2010
End Date
December 1 2014
Last Update
May 21 2014
Active Locations (2)
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1
Instituto Do Cancer Do Estado de São Paulo
São Paulo, São Paulo, Brazil, 01246-000
2
Hospital Sirio Libanes
São Paulo, São Paulo, Brazil, 01308-000