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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03683810
Enrollment
50
Registered
2018-09-25
Start date
2019-01-14
Completion date
2023-06-30
Last updated
2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

hemoglobin, quality of life

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTLactoferrin

Lactoferrin in tablets 4g/daily

DRUGRecombinant human erythropoietin

Recombinant human erythropoietin (rHuEPO, epoetin alfa)

Sponsors

Hematological Clinic - Nicosia General Hospital
CollaboratorUNKNOWN
German Oncology Center, Cyprus
CollaboratorOTHER
Limassol Hematology-oncology Center
CollaboratorUNKNOWN
Cyprus University of Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
HemoglobinChange from baseline at 2, 4, 6, 8, 10, 12Concentration of Hemoglobin levels in Serum

Secondary

MeasureTime frameDescription
CytokineChange from baseline at 2, 4, 6, 8, 10, 12 weeksConcentration of Cytokine Levels in Serum
LgGChange from baseline at 2, 4, 6, 8, 10, 12 weeksConcentration of LgG Levels in Serum
LgAChange from baseline at 2, 4, 6, 8, 10, 12 weeksConcentration of LgA Levels in Serum
FerritinChange from baseline at 2, 4, 6, 8, 10, 12Concentration of Ferritin Levels in Serum
General Quality of LIfeChange from baseline at 4, 8, 12 weeksEQ-5d
Health related quality of lifeChange from baseline at 4, 8, 12 weeksEORTC - QLQ C-30
Functional Assessment of Cancer Therapy AnemiaChange from baseline at 4, 8, 12 weeksFACT-An
LgMChange from baseline at 2, 4, 6, 8, 10, 12 weeksConcentration of LgM Levels in Serum

Countries

Cyprus

Contacts

Primary ContactAndreas CHARALAMBOUS, PhD
andreas.charalambous@cut.ac.cy99693478
Backup ContactMaria Christofi, MSc
m.christofi@cut.ac.cy99828713

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026