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

Phase 1

Recruiting

• Conditions: Anemia
• Interventions: Dietary Supplement: Lactoferrin; Drug: Recombinant human erythropoietin

• Registration Number: NCT03683810
• Lead Sponsor: Cyprus University of Technology

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.

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Study Start: 2019-01-14
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-06
• Primary Completion: 2023-01
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactoferrin	Lactoferrin	Participants will receive 4gr lactoferrin per day for a duration of 3 months + standard treatment for anemia
Lactoferrin	Recombinant human erythropoietin	Participants will receive 4gr lactoferrin per day for a duration of 3 months + standard treatment for anemia
Standard treatment	Recombinant human erythropoietin	Participants will receive only the standard treatment for anemia

Primary Outcome Measures

Name	Time	Method
Hemoglobin	Change from baseline at 2, 4, 6, 8, 10, 12	Concentration of Hemoglobin levels in Serum

Secondary Outcome Measures

Name	Time	Method
Ferritin	Change from baseline at 2, 4, 6, 8, 10, 12	Concentration of Ferritin Levels in Serum
LgA	Change from baseline at 2, 4, 6, 8, 10, 12 weeks	Concentration of LgA Levels in Serum
LgM	Change from baseline at 2, 4, 6, 8, 10, 12 weeks	Concentration of LgM Levels in Serum
Cytokine	Change from baseline at 2, 4, 6, 8, 10, 12 weeks	Concentration of Cytokine Levels in Serum
LgG	Change from baseline at 2, 4, 6, 8, 10, 12 weeks	Concentration of LgG Levels in Serum
General Quality of LIfe	Change from baseline at 4, 8, 12 weeks	EQ-5d
Health related quality of life	Change from baseline at 4, 8, 12 weeks	EORTC - QLQ C-30
Functional Assessment of Cancer Therapy Anemia	Change from baseline at 4, 8, 12 weeks	FACT-An

Trial Locations

Locations (2)

Nicosia General Hospital; 🇨🇾 Nicosia, Cyprus

Hematology-Oncology Center; 🇨🇾 Limassol, Cyprus