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

May 20, 2014 updated by: Instituto do Cancer do Estado de São Paulo

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 01308-000
        • Recruiting
        • Hospital Sírio Libanês
        • Sub-Investigator:
          • AKNAR CALABRICH, MD
        • Contact:
        • Principal Investigator:
          • PAULO HOFF, MD
    • SP
      • São Paulo, SP, Brazil, 01246-000
        • Recruiting
        • Instituto do Cancer do Estado de Sao Paulo
        • Contact:
        • Sub-Investigator:
          • AKNAR CALABRICH, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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; -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • NORIPURUM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens
Time Frame: 18 weeks
Anemia prevention defined by hemoglobin levels
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Collaborators

Fundação Faculdade de Medicina

Investigators

  • Principal Investigator: Paulo Hoff, MD Professor, Instituto do Cancer do Estado de Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

July 22, 2010

First Posted (Estimate)

July 23, 2010

Study Record Updates

Last Update Posted (Estimate)

May 21, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP 002/2009 - CEP 543/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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