Iron Supplement in the Prevention of Anemia in Female Breast Cancer Patients
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: ferric hydroxide saccharate
Type: Drug
Overall Status
Recruiting
Summary
Study to evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

1. Women older than 18 years

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:

1. Use of any oral supplement containing iron;

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; -
Locations
Instituto Do Cancer Do Estado de São Paulo
São Paulo, SP, Brazil
Status: Recruiting
Contact: MAX MANO, MD PHD - 55-11-38932646 - elaine.longo@icesp.org.br
Hospital Sirio Libanes
São Paulo, Brazil
Status: Recruiting
Contact: PAULO HOFF, MD - ++55-11-3155-0995 - rosana.batista@hsl.org.br
Start Date
May 2010
Completion Date
December 2014
Sponsors
Instituto do Cancer do Estado de São Paulo
Source
Instituto do Cancer do Estado de São Paulo
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page