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

• Sponsor: Cyprus University of Technology (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03683810
• Collaborator: Hematological Clinic - Nicosia General Hospital (Other)
• Enrollment: 50
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 40.5
• Patients Per Site: 25
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia	Dietary Supplement: Lactoferrin; Drug: Recombinant human erythropoietin	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effectiveness of Lactoferrin in the Management of Treatment-induced Anemia in Hematological Patients
• Actual Study Start Date: Jan 14, 2019
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Hemoglobin [Change from baseline at 2, 4, 6, 8, 10, 12]

   Concentration of Hemoglobin levels in Serum

Secondary Outcome Measures

1. Ferritin [Change from baseline at 2, 4, 6, 8, 10, 12]

   Concentration of Ferritin Levels in Serum

2. Cytokine [Change from baseline at 2, 4, 6, 8, 10, 12 weeks]

   Concentration of Cytokine Levels in Serum

3. LgG [Change from baseline at 2, 4, 6, 8, 10, 12 weeks]

   Concentration of LgG Levels in Serum

4. LgA [Change from baseline at 2, 4, 6, 8, 10, 12 weeks]

   Concentration of LgA Levels in Serum

5. LgM [Change from baseline at 2, 4, 6, 8, 10, 12 weeks]

   Concentration of LgM Levels in Serum

6. General Quality of LIfe [Change from baseline at 4, 8, 12 weeks]

   EQ-5d

7. Health related quality of life [Change from baseline at 4, 8, 12 weeks]

   EORTC - QLQ C-30

8. Functional Assessment of Cancer Therapy Anemia [Change from baseline at 4, 8, 12 weeks]

   FACT-An

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematology-Oncology Center	Limassol		Cyprus	3027
2	Nicosia General Hospital	Nicosia		Cyprus

Sponsors and Collaborators

• Cyprus University of Technology
• Hematological Clinic - Nicosia General Hospital

Investigators

• Principal Investigator: Andreas CHARALAMBOUS, Cyprus University of Technology (Nursing Department)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Andreas Charalambous, Associate Professor, Cyprus University of Technology
• ClinicalTrials.gov Identifier: NCT03683810
• Other Study ID Numbers: AC-LFS-2018
• First Posted: Sep 25, 2018
• Last Update Posted: Oct 6, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Andreas Charalambous, Associate Professor, Cyprus University of Technology: hemoglobin; quality of life
• Additional relevant MeSH terms: Anemia; Lactoferrin; Epoetin Alfa

Study Results

No Results Posted as of Oct 6, 2021