This will be a randomised control trial designed to test the effectiveness of lactoferrin in the management of treatment-induced anemia in patients with hematological malignancies.
Chemotherapy induced anemia (CIA) is a common adverse event in cancer patients reported to occur in 20-60% whilst the resulting low hemoglobin level is associated with impaired quality of life. Lactoferrin (LF) is a non-haem iron-binding protein that is part of the transferrin protein family, along with serum transferrin, ovotransferrin, melanotransferrin and the inhibitor of carbonic anhydrase, whose function is to transport iron in blood serum. The aim of the study is to test the effectiveness of LF along with standard care in the management of treatment-induced anemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Lactoferrin in tablets 4g/daily
Recombinant human erythropoietin (rHuEPO, epoetin alfa)
Hematology-Oncology Center
Limassol, Cyprus
RECRUITINGNicosia General Hospital
Nicosia, Cyprus
RECRUITINGHemoglobin
Concentration of Hemoglobin levels in Serum
Time frame: Change from baseline at 2, 4, 6, 8, 10, 12
Ferritin
Concentration of Ferritin Levels in Serum
Time frame: Change from baseline at 2, 4, 6, 8, 10, 12
Cytokine
Concentration of Cytokine Levels in Serum
Time frame: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
LgG
Concentration of LgG Levels in Serum
Time frame: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
LgA
Concentration of LgA Levels in Serum
Time frame: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
LgM
Concentration of LgM Levels in Serum
Time frame: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
General Quality of LIfe
EQ-5d
Time frame: Change from baseline at 4, 8, 12 weeks
Health related quality of life
EORTC - QLQ C-30
Time frame: Change from baseline at 4, 8, 12 weeks
Functional Assessment of Cancer Therapy Anemia
FACT-An
Time frame: Change from baseline at 4, 8, 12 weeks
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