Back to resultsIron Supplement in the Prevention of Anemia in Female Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
ferric hydroxide saccharate
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer
Eligibility 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; -
Sites / Locations
- Instituto Do Cancer Do Estado de São PauloRecruiting
- Hospital Sirio LibanesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
no iron supplentation
iron supplement
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01168505
First Posted
July 21, 2010
Last Updated
May 20, 2014
Sponsor
Instituto do Cancer do Estado de São Paulo
Collaborators
Fundação Faculdade de Medicina
1. Study Identification
Unique Protocol Identification Number
NCT01168505
Brief Title
Iron Supplement in the Prevention of Anemia in Female Breast Cancer Patients
Official Title
The Role of Intravenous Iron to Prevent Anemia in Women With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo
Collaborators
Fundação Faculdade de Medicina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
no iron supplentation
Arm Type
No Intervention
Arm Title
iron supplement
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ferric hydroxide saccharate
Other Intervention Name(s)
NORIPURUM
Intervention Description
single dose of 200 mg (2 ampoules), 24-48 hours after administration of chemotherapy for a total of four doses
Primary Outcome Measure Information:
Title
Evaluate the efficacy of intravenous iron supplementation in the prevention of anemia in patients receiving (neo)adjuvant breast cancer regimens
Description
Anemia prevention defined by hemoglobin levels
Time Frame
18 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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; -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PAULO HOFF, MD Prof.
Phone
++55-11-38932619
Email
juliana.paula@icesp.org.br
First Name & Middle Initial & Last Name or Official Title & Degree
ROBERTO ARAI, Pharm PHD
Phone
++55-11-38932619
Email
roberto.arai@icesp.org.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo Hoff, MD Professor
Organizational Affiliation
Instituto do Câncer do Estado de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Do Cancer Do Estado de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MAX MANO, MD PHD
Phone
55-11-38932646
Email
elaine.longo@icesp.org.br
First Name & Middle Initial & Last Name & Degree
Aknar Calabrich, MD
Facility Name
Hospital Sirio Libanes
City
São Paulo
ZIP/Postal Code
01308-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PAULO HOFF, MD
Phone
++55-11-3155-0995
Email
rosana.batista@hsl.org.br
First Name & Middle Initial & Last Name & Degree
PAULO HOFF, MD
First Name & Middle Initial & Last Name & Degree
AKNAR CALABRICH, MD
12. IPD Sharing Statement
Learn more about this trial
Iron Supplement in the Prevention of Anemia in Female Breast Cancer Patients
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