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

This study is currently recruiting participants.

Verified May 2010 by University of Sao Paulo

Sponsor:

Collaborator:

Fundação Faculdade de Medicina

Information provided by:

University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01168505

First received: July 21, 2010

Last updated: November 9, 2010

Last verified: May 2010

History of Changes

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Anemia Breast Cancer Cancer Dietary Supplements Iron

U.S. FDA Resources

Further study details as provided by University of Sao 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:	May 2014
Estimated Primary Completion Date:	May 2012 (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:

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.

Exclusion Criteria:

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; -

Contacts and Locations

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

University of Sao 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:	PAULO MARCELO GEHM HOFF, INSTITUTO DO CANCER DO ESTADO DE SÃO PAULO
ClinicalTrials.gov Identifier:	NCT01168505 History of Changes
Other Study ID Numbers:	543/09
Study First Received:	July 21, 2010
Last Updated:	November 9, 2010
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 May 16, 2013

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