The Effectiveness of Lactoferrin in the Management of Treatment-induced Anemia
1 other identifier
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2019
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2018
CompletedFirst Posted
Study publicly available on registry
September 25, 2018
CompletedStudy Start
First participant enrolled
January 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedSeptember 6, 2022
September 1, 2022
4 years
September 24, 2018
September 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin
Concentration of Hemoglobin levels in Serum
Change from baseline at 2, 4, 6, 8, 10, 12
Secondary Outcomes (8)
Ferritin
Change from baseline at 2, 4, 6, 8, 10, 12
Cytokine
Change from baseline at 2, 4, 6, 8, 10, 12 weeks
LgG
Change from baseline at 2, 4, 6, 8, 10, 12 weeks
LgA
Change from baseline at 2, 4, 6, 8, 10, 12 weeks
LgM
Change from baseline at 2, 4, 6, 8, 10, 12 weeks
- +3 more secondary outcomes
Study Arms (2)
Lactoferrin
EXPERIMENTALParticipants will receive 4gr lactoferrin per day for a duration of 3 months + standard treatment for anemia
Standard treatment
ACTIVE COMPARATORParticipants will receive only the standard treatment for anemia
Interventions
Recombinant human erythropoietin (rHuEPO, epoetin alfa)
Eligibility Criteria
You may qualify if:
- Patients on active treatment (chemotherapy i.e. cyclophosphamide, doxorubicin, rituximab, cisplatin carboplatin, etoposide)
- Ability to independently complete the questionnaires
You may not qualify if:
- Allergy to Milk
- Lactose intolerance
- Celiac disease
- Patient of whom chemotherapy has been interrupted for more than 2 weeks (due to adverse effects)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cyprus University of Technologylead
- Hematological Clinic - Nicosia General Hospitalcollaborator
- German Oncology Center, Cypruscollaborator
- Limassol Hematology-oncology Centercollaborator
Study Sites (2)
Hematology-Oncology Center
Limassol, 3027, Cyprus
Nicosia General Hospital
Nicosia, Cyprus
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas CHARALAMBOUS
Cyprus University of Technology (Nursing Department)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 24, 2018
First Posted
September 25, 2018
Study Start
January 14, 2019
Primary Completion
January 1, 2023
Study Completion
June 1, 2023
Last Updated
September 6, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share