Iron Supplement in the Prevention of Anemia in Female Breast Cancer Patients
NCT ID: NCT01168505
Last Updated: 2014-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2010-05-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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no iron supplentation
No interventions assigned to this group
iron supplement
ferric hydroxide saccharate
single dose of 200 mg (2 ampoules), 24-48 hours after administration of chemotherapy for a total of four doses
Interventions
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ferric hydroxide saccharate
single dose of 200 mg (2 ampoules), 24-48 hours after administration of chemotherapy for a total of four doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient with operated breast cancer with indication for (NEO)adjuvant therapy
3. 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.
4. Lack of folic acid deficiency and vitamin B12
5. Able to provide written informed consent.
Exclusion Criteria
2. Patients who have iron overload as defined by serum ferritin\> 800 microg / L or transferrin saturation\> 40%;
3. Patients who are pregnant or breastfeeding;
4. History of active infection or active bleeding except menstruation;
5. History of HIV or hepatitis B or C - clinically important; -
18 Years
FEMALE
No
Sponsors
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Fundação Faculdade de Medicina
OTHER
Instituto do Cancer do Estado de São Paulo
OTHER
Responsible Party
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Principal Investigators
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Paulo Hoff, MD Professor
Role: PRINCIPAL_INVESTIGATOR
Instituto do Câncer do Estado de São Paulo
Locations
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Instituto Do Cancer Do Estado de São Paulo
São Paulo, São Paulo, Brazil
Hospital Sirio Libanes
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NP 002/2009 - CEP 543/09
Identifier Type: -
Identifier Source: org_study_id
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