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

C

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)

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

Trial contacts and locations

2

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Central trial contact

Andreas CHARALAMBOUS, PhD; Maria Christofi, MSc

Data sourced from clinicaltrials.gov

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