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

Cyprus University of Technology

Status and phase: Enrolling; Phase 1

Conditions: Anemia

Treatments: Dietary Supplement: Lactoferrin; Drug: Recombinant human erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT03683810

AC-LFS-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Lactoferrin

Experimental group

Description:

Participants will receive 4gr lactoferrin per day for a duration of 3 months + standard treatment for anemia

Treatment:

Dietary Supplement: Lactoferrin

Drug: Recombinant human erythropoietin

Standard treatment

Active Comparator group

Description:

Participants will receive only the standard treatment for anemia

Treatment:

Drug: Recombinant human erythropoietin