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

Primary Purpose

Anemia

Status

Recruiting

Phase

Phase 1

Locations

Cyprus

Study Type

Interventional

Intervention

Lactoferrin

Recombinant human erythropoietin

About this trial

This is an interventional treatment trial for Anemia focused on measuring hemoglobin, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Hematology-Oncology CenterRecruiting
Nicosia General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lactoferrin

Standard treatment

Arm Description

Participants will receive 4gr lactoferrin per day for a duration of 3 months + standard treatment for anemia

Participants will receive only the standard treatment for anemia

Outcomes

Primary Outcome Measures

Hemoglobin

Concentration of Hemoglobin levels in Serum

Secondary Outcome Measures

Ferritin

Concentration of Ferritin Levels in Serum

Cytokine

Concentration of Cytokine Levels in Serum

LgG

Concentration of LgG Levels in Serum

LgA

Concentration of LgA Levels in Serum

LgM

Concentration of LgM Levels in Serum

General Quality of LIfe

EQ-5d

Health related quality of life

EORTC - QLQ C-30

Functional Assessment of Cancer Therapy Anemia

FACT-An

Full Information

NCT ID

NCT03683810

First Posted

September 24, 2018

Last Updated

September 1, 2022

Sponsor

Cyprus University of Technology

Collaborators

Hematological Clinic - Nicosia General Hospital, German Oncology Center, Cyprus, Limassol Hematology-oncology Center

1. Study Identification

Unique Protocol Identification Number

NCT03683810

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 14, 2019 (Actual)

Primary Completion Date

January 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cyprus University of Technology

Collaborators

Hematological Clinic - Nicosia General Hospital, German Oncology Center, Cyprus, Limassol Hematology-oncology Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia

Keywords

hemoglobin, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lactoferrin

Arm Type

Experimental

Arm Description

Participants will receive 4gr lactoferrin per day for a duration of 3 months + standard treatment for anemia

Arm Title

Standard treatment

Arm Type

Active Comparator

Arm Description

Participants will receive only the standard treatment for anemia

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactoferrin

Intervention Description

Lactoferrin in tablets 4g/daily

Intervention Type

Drug

Intervention Name(s)

Recombinant human erythropoietin

Intervention Description

Recombinant human erythropoietin (rHuEPO, epoetin alfa)

Primary Outcome Measure Information:

Title

Hemoglobin

Description

Concentration of Hemoglobin levels in Serum

Time Frame

Change from baseline at 2, 4, 6, 8, 10, 12

Secondary Outcome Measure Information:

Title

Ferritin

Description

Concentration of Ferritin Levels in Serum

Time Frame

Change from baseline at 2, 4, 6, 8, 10, 12

Title

Cytokine

Description

Concentration of Cytokine Levels in Serum

Time Frame

Change from baseline at 2, 4, 6, 8, 10, 12 weeks

Title

LgG

Description

Concentration of LgG Levels in Serum

Time Frame

Change from baseline at 2, 4, 6, 8, 10, 12 weeks

Title

LgA

Description

Concentration of LgA Levels in Serum

Time Frame

Change from baseline at 2, 4, 6, 8, 10, 12 weeks

Title

LgM

Description

Concentration of LgM Levels in Serum

Time Frame

Change from baseline at 2, 4, 6, 8, 10, 12 weeks

Title

General Quality of LIfe

Description

EQ-5d

Time Frame

Change from baseline at 4, 8, 12 weeks

Title

Health related quality of life

Description

EORTC - QLQ C-30

Time Frame

Change from baseline at 4, 8, 12 weeks

Title

Functional Assessment of Cancer Therapy Anemia

Description

FACT-An

Time Frame

Change from baseline at 4, 8, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andreas CHARALAMBOUS, PhD

Phone

99693478

andreas.charalambous@cut.ac.cy

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Christofi, MSc

Phone

99828713

m.christofi@cut.ac.cy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas CHARALAMBOUS

Organizational Affiliation

Cyprus University of Technology (Nursing Department)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hematology-Oncology Center

City

Limassol

ZIP/Postal Code

3027

Country

Cyprus

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Vergoulidou

Phone

25320247

info@hematology-oncology-center.com

Facility Name

Nicosia General Hospital

City

Nicosia

Country

Cyprus

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Freideriki Melanthiou, MD

Phone

22603461

kmelanth@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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