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

NCT ID: NCT01168505

Last Updated: 2014-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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no iron supplentation

Group Type NO_INTERVENTION

No interventions assigned to this group

iron supplement

Group Type EXPERIMENTAL

ferric hydroxide saccharate

Intervention Type DRUG

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

Interventions

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ferric hydroxide saccharate

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

Intervention Type DRUG

Other Intervention Names

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NORIPURUM

Eligibility Criteria

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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; -
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fundação Faculdade de Medicina

OTHER

Sponsor Role collaborator

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paulo Hoff, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Instituto do Câncer do Estado de São Paulo

Locations

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Instituto Do Cancer Do Estado de São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Hospital Sirio Libanes

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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PAULO HOFF, MD Prof.

Role: CONTACT

++55-11-38932619

ROBERTO ARAI, Pharm PHD

Role: CONTACT

++55-11-38932619

Facility Contacts

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MAX MANO, MD PHD

Role: primary

55-11-38932646

PAULO HOFF, MD

Role: primary

++55-11-3155-0995

Other Identifiers

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NP 002/2009 - CEP 543/09

Identifier Type: -

Identifier Source: org_study_id

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