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

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia
• Intervention / Treatment: Dietary supplement: Lactoferrin; Drug: Recombinant human erythropoietin

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Andreas CHARALAMBOUS, PhD; Phone Number: 99693478; Email: andreas.charalambous@cut.ac.cy
• Study Contact Backup: Name: Maria Christofi, MSc; Phone Number: 99828713; Email: m.christofi@cut.ac.cy

Study Locations

• Cyprus
  • Limassol, Cyprus, 3027
    • Recruiting
    • Hematology-Oncology Center
    • Contact: Maria Vergoulidou; Phone Number: 25320247; Email: info@hematology-oncology-center.com
  • Nicosia, Cyprus
    • Recruiting
    • Nicosia General Hospital
    • Contact: Freideriki Melanthiou, MD; Phone Number: 22603461; Email: kmelanth@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactoferrin; Participants will receive 4gr lactoferrin per day for a duration of 3 months + standard treatment for anemia	Dietary supplement: Lactoferrin; Lactoferrin in tablets 4g/daily; Drug: Recombinant human erythropoietin; Recombinant human erythropoietin (rHuEPO, epoetin alfa)
Active Comparator: Standard treatment; Participants will receive only the standard treatment for anemia	Drug: Recombinant human erythropoietin; Recombinant human erythropoietin (rHuEPO, epoetin alfa)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin	Concentration of Hemoglobin levels in Serum	Change from baseline at 2, 4, 6, 8, 10, 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cyprus University of Technology
• Collaborators: German Oncology Center, Cyprus; Hematological Clinic - Nicosia General Hospital; Limassol Hematology-oncology Center
• Investigators: Principal Investigator: Andreas CHARALAMBOUS, Cyprus University of Technology (Nursing Department)

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; hemoglobin
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia; Anti-Infective Agents; Hematinics; Epoetin Alfa; Lactoferrin
• Other Study ID Numbers: AC-LFS-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No