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

I

Instituto do Cancer do Estado de São Paulo

Status and phase

Unknown
Phase 2

Conditions

Breast Cancer

Treatments

Drug: ferric hydroxide saccharate

Study type

Interventional

Funder types

Other

Identifiers

NCT01168505
NP 002/2009 - CEP 543/09

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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; -

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

no iron supplentation
No Intervention group
iron supplement
Experimental group
Treatment:
Drug: ferric hydroxide saccharate

Trial contacts and locations

2

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Central trial contact

PAULO HOFF, MD Prof.; ROBERTO ARAI, Pharm PHD

Data sourced from clinicaltrials.gov

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