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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01168505
• Other study ID #: NP 002/2009 - CEP 543/09
• Status: Recruiting
• Phase: Phase 2
• First received: July 21, 2010
• Last updated: May 20, 2014
• Start date: May 2010
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: PAULO HOFF, MD Prof.
• Phone: ++55-11-38932619
• Email: juliana.paula[@]icesp.org.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• ferric hydroxide saccharate
single dose of 200 mg (2 ampoules), 24-48 hours after administration of chemotherapy for a total of four doses

Locations

Country	Name	City	State
Brazil	Hospital Sirio Libanes	São Paulo
Brazil	Instituto Do Cancer Do Estado de São Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo	Fundação Faculdade de Medicina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens	Anemia prevention defined by hemoglobin levels	18 weeks	No