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| Name | Class |
|---|---|
| Hematological Clinic - Nicosia General Hospital | UNKNOWN |
| German Oncology Center, Cyprus | OTHER |
| Limassol Hematology-oncology Center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactoferrin | Experimental | Participants will receive 4gr lactoferrin per day for a duration of 3 months + standard treatment for anemia |
|
| Standard treatment | Active Comparator | Participants will receive only the standard treatment for anemia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactoferrin | Dietary Supplement | Lactoferrin in tablets 4g/daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | Concentration of Hemoglobin levels in Serum | Change from baseline at 2, 4, 6, 8, 10, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Ferritin | Concentration of Ferritin Levels in Serum | Change from baseline at 2, 4, 6, 8, 10, 12 |
| Cytokine | Concentration of Cytokine Levels in Serum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas CHARALAMBOUS, PhD | Contact | 99693478 | andreas.charalambous@cut.ac.cy | |
| Maria Christofi, MSc | Contact | 99828713 | m.christofi@cut.ac.cy |
| Name | Affiliation | Role |
|---|---|---|
| Andreas CHARALAMBOUS | Cyprus University of Technology (Nursing Department) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology-Oncology Center | Recruiting | Limassol | 3027 | Cyprus |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007781 | Lactoferrin |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Recombinant human erythropoietin |
| Drug |
Recombinant human erythropoietin (rHuEPO, epoetin alfa) |
|
| Change from baseline at 2, 4, 6, 8, 10, 12 weeks |
| LgG | Concentration of LgG Levels in Serum | Change from baseline at 2, 4, 6, 8, 10, 12 weeks |
| LgA | Concentration of LgA Levels in Serum | Change from baseline at 2, 4, 6, 8, 10, 12 weeks |
| LgM | Concentration of LgM Levels in Serum | Change from baseline at 2, 4, 6, 8, 10, 12 weeks |
| General Quality of LIfe | EQ-5d | Change from baseline at 4, 8, 12 weeks |
| Health related quality of life | EORTC - QLQ C-30 | Change from baseline at 4, 8, 12 weeks |
| Functional Assessment of Cancer Therapy Anemia | FACT-An | Change from baseline at 4, 8, 12 weeks |
| Nicosia General Hospital | Recruiting | Nicosia | Cyprus |
|
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D061250 | Transferrins |
| D033862 | Iron-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007782 | Lactoglobulins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005916 | Globulins |
| D008667 | Metalloproteins |