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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01168505

Enrollment

100

Registered

2010-07-23

Start date

2010-05-31

Completion date

2014-12-31

Last updated

2014-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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

Interventions

DRUGferric hydroxide saccharate

single dose of 200 mg (2 ampoules), 24-48 hours after administration of chemotherapy for a total of four doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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; -

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Brazil

Contacts

Primary ContactPAULO HOFF, MD Prof.

juliana.paula@icesp.org.br++55-11-38932619

Backup ContactROBERTO ARAI, Pharm PHD

roberto.arai@icesp.org.br++55-11-38932619

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026