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

NCT01168505 | Unknown Phase 2

• 1 other identifier: NP 002/2009 - CEP 543/09
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

no iron supplentation

NO INTERVENTION

iron supplement

EXPERIMENTAL

Drug: ferric hydroxide saccharate

Interventions

ferric hydroxide saccharate DRUG

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

Also known as: NORIPURUM

iron supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women older than 18 years
• Patient with operated breast cancer with indication for (NEO)adjuvant therapy
• 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.
• Lack of folic acid deficiency and vitamin B12
• Able to provide written informed consent.

You may not qualify if:

• Use of any oral supplement containing iron;
• Patients who have iron overload as defined by serum ferritin\> 800 microg / L or transferrin saturation\> 40%;
• Patients who are pregnant or breastfeeding;
• History of active infection or active bleeding except menstruation;
• History of HIV or hepatitis B or C - clinically important; -

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• Fundação Faculdade de Medicina: collaborator

Study Sites (2)

Instituto Do Cancer Do Estado de São Paulo

São Paulo, São Paulo, 01246-000, Brazil

RECRUITING

Hospital Sirio Libanes

São Paulo, São Paulo, 01308-000, Brazil

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

teferrol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Paulo Hoff, MD Professor

  Instituto do Câncer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PAULO HOFF, MD Prof.

CONTACT

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

ROBERTO ARAI, Pharm PHD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2010
• First Posted: July 23, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

BR (2)