The Effectiveness of Lactoferrin in the Management of Treatment-induced Anemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effectiveness of Lactoferrin in the Management of Treatment-induced Anemia in Hematological Patients

Conditions
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Anemia

Intervention / Treatment
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* Dietary Supplement: Lactoferrin
* Drug: Recombinant human erythropoietin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients on active treatment (chemotherapy i.e. cyclophosphamide, doxorubicin, rituximab, cisplatin carboplatin, etoposide) Ability to independently complete the questionnaires Exclusion Criteria: Allergy to Milk Lactose intolerance Celiac disease Patient of whom chemotherapy has been interrupted for more than 2 weeks (due to adverse effects)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactoferrin<br>Participants will receive 4gr lactoferrin per day for a duration of 3 months + standard treatment for anemia | Dietary Supplement: Lactoferrin<br>* Lactoferrin in tablets 4g/daily<br>Drug: Recombinant human erythropoietin<br>* Recombinant human erythropoietin (rHuEPO, epoetin alfa)<br>|
| Active Comparator: Standard treatment<br>Participants will receive only the standard treatment for anemia | Drug: Recombinant human erythropoietin<br>* Recombinant human erythropoietin (rHuEPO, epoetin alfa)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin | Concentration of Hemoglobin levels in Serum | Change from baseline at 2, 4, 6, 8, 10, 12 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemoglobin, quality of life