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The Role of Intravenous Iron to Prevent Anemia in Women With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

The Role of Intravenous Iron to Prevent Anemia in Women With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy


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; -

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens

Outcome Description:

Anemia prevention defined by hemoglobin levels

Outcome Time Frame:

18 weeks

Safety Issue:

No

Principal Investigator

Paulo Hoff, MD Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Instituto do Câncer do Estado de São Paulo

Authority:

Brazil: Ethics Committee

Study ID:

543/09

NCT ID:

NCT01168505

Start Date:

May 2010

Completion Date:

May 2014

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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