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Trial Title:
Iron Supplement in the Prevention of Anemia in Female Breast Cancer Patients
NCT ID:
NCT01168505
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Teferrol
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ferric hydroxide saccharate
Description:
single dose of 200 mg (2 ampoules), 24-48 hours after administration of chemotherapy for
a total of four doses
Arm group label:
iron supplement
Other name:
NORIPURUM
Summary:
Study to evaluate the efficacy of intravenous iron supplementation in the prevention of
anemia in patients receiving (neo)adjuvant breast cancer regimens.
Criteria for eligibility:
Criteria:
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; -
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Instituto Do Cancer Do Estado de São Paulo
Address:
City:
São Paulo
Zip:
01246-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
MAX MANO, MD PHD
Phone:
55-11-38932646
Email:
elaine.longo@icesp.org.br
Investigator:
Last name:
Aknar Calabrich, MD
Email:
Sub-Investigator
Facility:
Name:
Hospital Sirio Libanes
Address:
City:
São Paulo
Zip:
01308-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
PAULO HOFF, MD
Phone:
++55-11-3155-0995
Email:
rosana.batista@hsl.org.br
Investigator:
Last name:
PAULO HOFF, MD
Email:
Principal Investigator
Investigator:
Last name:
AKNAR CALABRICH, MD
Email:
Sub-Investigator
Start date:
May 2010
Completion date:
December 2014
Lead sponsor:
Agency:
Instituto do Cancer do Estado de São Paulo
Agency class:
Other
Collaborator:
Agency:
Fundação Faculdade de Medicina
Agency class:
Other
Source:
Instituto do Cancer do Estado de São Paulo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01168505
