A Phase 1 interventional study of Lactoferrin and Recombinant human erythropoietin in Anemia, sponsored by Cyprus University of Technology. Status unknown at 2 sites in Cyprus. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-06.
Sponsored by Cyprus University of Technology · Phase 1, Interventional, and Treatment
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.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's planned enrollment of 50 is below the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Cyprus University of Technology is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive 4gr lactoferrin per day for a duration of 3 months + standard treatment for anemia
Dietary Supplement: Lactoferrin · Drug: Recombinant human erythropoietin
Participants will receive only the standard treatment for anemia
Drug: Recombinant human erythropoietin
Lactoferrin in tablets 4g/daily
Recombinant human erythropoietin (rHuEPO, epoetin alfa)
Hemoglobin
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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cyprus University of Technology