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

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

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: ferric hydroxide saccharate

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01308-000
    • Recruiting
    • Hospital Sirio Libanes
    • Sub-Investigator: AKNAR CALABRICH, MD
    • Contact: PAULO HOFF, MD; Phone Number: ++55-11-3155-0995; Email: rosana.batista@hsl.org.br
    • Principal Investigator: PAULO HOFF, MD
  • SP
    • São Paulo, SP, Brazil, 01246-000
      • Recruiting
      • Instituto do Cancer do Estado de São Paulo
      • Contact: MAX MANO, MD PHD; Phone Number: 55-11-38932646; Email: elaine.longo@icesp.org.br
      • Sub-Investigator: AKNAR CALABRICH, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: no iron supplentation
Experimental: iron supplement	Drug: ferric hydroxide saccharate; single dose of 200 mg (2 ampoules), 24-48 hours after administration of chemotherapy for a total of four doses; Other Names: NORIPURUM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo
• Collaborators: Fundação Faculdade de Medicina
• Investigators: Principal Investigator: Paulo Hoff, MD Professor, Instituto do Cancer do Estado de São Paulo

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: July 21, 2010
• First Submitted That Met QC Criteria: July 22, 2010
• First Posted (Estimate): July 23, 2010

Study Record Updates

• Last Update Posted (Estimate): May 21, 2014
• Last Update Submitted That Met QC Criteria: May 20, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Hematinics; Teferrol
• Other Study ID Numbers: NP 002/2009 - CEP 543/09