Iron Supplement in the Prevention of Anemia in Female Breast Cancer Patients

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: ferric hydroxide saccharate

• Registration Number: NCT01168505
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief Summary

Study to evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-22
• Study First Posted: 2010-07-23
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-21
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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; -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iron supplement	ferric hydroxide saccharate	-

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens	18 weeks	Anemia prevention defined by hemoglobin levels

Trial Locations

Locations (2)

Instituto Do Cancer Do Estado de São Paulo; 🇧🇷 São Paulo, SP, Brazil

Hospital Sirio Libanes; 🇧🇷 São Paulo, Brazil