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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03683810
• Other study ID #: AC-LFS-2018
• Status: Recruiting
• Phase: Phase 1
• Start date: January 14, 2019
• Est. completion date: June 2023

Study information

• Verified date: September 2022
• Source: Cyprus University of Technology
• Contact: Andreas CHARALAMBOUS, PhD
• Phone: 99693478
• Email: andreas.charalambous[@]cut.ac.cy
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anemia

Intervention

Dietary Supplement:
• Lactoferrin
Lactoferrin in tablets 4g/daily

Drug:
• Recombinant human erythropoietin
Recombinant human erythropoietin (rHuEPO, epoetin alfa)

Locations

Country	Name	City	State
Cyprus	Hematology-Oncology Center	Limassol
Cyprus	Nicosia General Hospital	Nicosia

Sponsors (4)

Lead Sponsor	Collaborator
Cyprus University of Technology	German Oncology Center, Cyprus, Hematological Clinic - Nicosia General Hospital, Limassol Hematology-oncology Center

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin	Concentration of Hemoglobin levels in Serum	Change from baseline at 2, 4, 6, 8, 10, 12
Secondary	Ferritin	Concentration of Ferritin Levels in Serum	Change from baseline at 2, 4, 6, 8, 10, 12
Secondary	Cytokine	Concentration of Cytokine Levels in Serum	Change from baseline at 2, 4, 6, 8, 10, 12 weeks
Secondary	LgG	Concentration of LgG Levels in Serum	Change from baseline at 2, 4, 6, 8, 10, 12 weeks
Secondary	LgA	Concentration of LgA Levels in Serum	Change from baseline at 2, 4, 6, 8, 10, 12 weeks
Secondary	LgM	Concentration of LgM Levels in Serum	Change from baseline at 2, 4, 6, 8, 10, 12 weeks
Secondary	General Quality of LIfe	EQ-5d	Change from baseline at 4, 8, 12 weeks
Secondary	Health related quality of life	EORTC - QLQ C-30	Change from baseline at 4, 8, 12 weeks
Secondary	Functional Assessment of Cancer Therapy Anemia	FACT-An	Change from baseline at 4, 8, 12 weeks