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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Instituto do Cancer do Estado de São Paulo
Sponsor:
Collaborator:
Fundação Faculdade de Medicina
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT01168505
First received: July 21, 2010
Last updated: May 20, 2014
Last verified: May 2014

July 21, 2010
May 20, 2014
May 2010
December 2014   (final data collection date for primary outcome measure)
Evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Anemia prevention defined by hemoglobin levels
Same as current
Complete list of historical versions of study NCT01168505 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Breast Cancer
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 Name: NORIPURUM
  • No Intervention: no iron supplentation
  • Experimental: iron supplement
    Intervention: Drug: ferric hydroxide saccharate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

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; -
Female
18 Years and older
No
Contact: PAULO HOFF, MD Prof. ++55-11-38932619 juliana.paula@icesp.org.br
Contact: ROBERTO ARAI, Pharm PHD ++55-11-38932619 roberto.arai@icesp.org.br
Brazil
 
NCT01168505
NP 002/2009 - CEP 543/09
No
Instituto do Cancer do Estado de São Paulo
Instituto do Cancer do Estado de São Paulo
Fundação Faculdade de Medicina
Principal Investigator: Paulo Hoff, MD Professor Instituto do Câncer do Estado de São Paulo
Instituto do Cancer do Estado de São Paulo
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP