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
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: ferric hydroxide saccharate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Role of Intravenous Iron to Prevent Anemia in Women With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by Instituto do Cancer do Estado de São Paulo:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: NORIPURUM

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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; -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168505

Contacts
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

Locations
Brazil
Instituto Do Cancer Do Estado de São Paulo Recruiting
São Paulo, SP, Brazil, 01246-000
Contact: MAX MANO, MD PHD    55-11-38932646    elaine.longo@icesp.org.br   
Sub-Investigator: Aknar Calabrich, MD         
Hospital Sirio Libanes Recruiting
São Paulo, Brazil, 01308-000
Contact: PAULO HOFF, MD    ++55-11-3155-0995    rosana.batista@hsl.org.br   
Principal Investigator: PAULO HOFF, MD         
Sub-Investigator: AKNAR CALABRICH, MD         
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Fundação Faculdade de Medicina
Investigators
Principal Investigator: Paulo Hoff, MD Professor Instituto do Câncer do Estado de São Paulo
  More Information

No publications provided

Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT01168505     History of Changes
Other Study ID Numbers: NP 002/2009 - CEP 543/09
Study First Received: July 21, 2010
Last Updated: May 20, 2014
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014