AnemiaPhase 1NCT03683810
The Effectiveness of Lactoferrin in the Management of Treatment-induced Anemia
A Phase 1 study testing Lactoferrin and Recombinant human erythropoietin in people with Anemia, run by Cyprus University of Technology at 2 sites in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Lactoferrin and Recombinant human erythropoietin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCyprus
- Study dates
- 14 Jan 2019to Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on active treatment (chemotherapy i.e. cyclophosphamide, doxorubicin, rituximab, cisplatin carboplatin, etoposide)
- Ability to independently complete the questionnaires
Who cannot join
- Allergy to Milk
- Lactose intolerance
- Celiac disease
- Patient of whom chemotherapy has been interrupted for more than 2 weeks (due to adverse effects)
Trial locations and contacts
2 sites in 1 country.
Cyprus2 sites, 2 recruiting
- Recruiting
Hematology-Oncology Center
Limassol, 3027
Maria Vergoulidou, 25320247, info@hematology-oncology-center.com
- Recruiting
Nicosia General Hospital
Nicosia
Freideriki Melanthiou, MD, 22603461, kmelanth@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Anemia
- Being tested
- Lactoferrin, Recombinant human erythropoietin
- Keywords
- hemoglobin, quality of life
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoferrinDietary supplement
Lactoferrin in tablets 4g/daily
Recombinant human erythropoietinDrug
Recombinant human erythropoietin (rHuEPO, epoetin alfa)
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin | Experimental | Participants will receive 4gr lactoferrin per day for a duration of 3 months + standard treatment for anemia Receives: Dietary Supplement: Lactoferrin; Drug: Recombinant human erythropoietin |
| Standard treatment | Active comparator | Participants will receive only the standard treatment for anemia Receives: Drug: Recombinant human erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Concentration of Hemoglobin levels in Serum
Measured: Change from baseline at 2, 4, 6, 8, 10, 12
Secondary outcomes (8)
Ferritin
Concentration of Ferritin Levels in Serum
Measured: Change from baseline at 2, 4, 6, 8, 10, 12
Cytokine
Concentration of Cytokine Levels in Serum
Measured: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
LgG
Concentration of LgG Levels in Serum
Measured: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
LgA
Concentration of LgA Levels in Serum
Measured: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
LgM
Concentration of LgM Levels in Serum
Measured: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
General Quality of LIfe
EQ-5d
Measured: Change from baseline at 4, 8, 12 weeks
Health related quality of life
EORTC - QLQ C-30
Measured: Change from baseline at 4, 8, 12 weeks
Functional Assessment of Cancer Therapy Anemia
FACT-An
Measured: Change from baseline at 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start14 Jan 2019
- Primary completionJan 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Hematological Clinic - Nicosia General Hospital, German Oncology Center, Cyprus, Limassol Hematology-oncology Center
- Responsible party
- Principal investigator, Dr. Andreas Charalambous, Cyprus University of Technology
- Investigators
- Andreas CHARALAMBOUS, Principal investigator, Cyprus University of Technology (Nursing Department)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683810
- Sponsor's protocol ID
- AC-LFS-2018
- Status last verified
- Sep 2022
- First submitted
- 24 Sep 2018
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Lactoferrin in the Management of Treatment-induced Anemia in Hematological Patients
- ClinicalTrials.gov ID
- NCT03683810
- Acronym / sponsor ID
- AC-LFS-2018
- Conditions
- Anemia
- Keywords
- hemoglobin, quality of life
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Collaborators
- Hematological Clinic - Nicosia General Hospital, German Oncology Center, Cyprus, Limassol Hematology-oncology Center
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin | Experimental | Dietary Supplement: Lactoferrin, Drug: Recombinant human erythropoietinParticipants will receive 4gr lactoferrin per day for a duration of 3 months + standard treatment for anemia |
| Standard treatment | Active comparator | Drug: Recombinant human erythropoietinParticipants will receive only the standard treatment for anemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients on active treatment (chemotherapy i.e. cyclophosphamide, doxorubicin, rituximab, cisplatin carboplatin, etoposide)
- Ability to independently complete the questionnaires
Key exclusion criteria (4 listed)
- Allergy to Milk
- Lactose intolerance
- Celiac disease
- Patient of whom chemotherapy has been interrupted for more than 2 weeks (due to adverse effects)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactoferrinLactoferrin in tablets 4g/daily | Dietary supplement | Lactoferrin |
| Recombinant human erythropoietinRecombinant human erythropoietin (rHuEPO, epoetin alfa) | Drug | Lactoferrin, Standard treatment |
Primary outcome
Hemoglobin
Time frame: Change from baseline at 2, 4, 6, 8, 10, 12
Concentration of Hemoglobin levels in Serum
8 secondary outcomes
Ferritin
Time frame: Change from baseline at 2, 4, 6, 8, 10, 12
Cytokine
Time frame: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
LgG
Time frame: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
LgA
Time frame: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
LgM
Time frame: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
General Quality of LIfe
Time frame: Change from baseline at 4, 8, 12 weeks
Health related quality of life
Time frame: Change from baseline at 4, 8, 12 weeks
Functional Assessment of Cancer Therapy Anemia
Time frame: Change from baseline at 4, 8, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas CHARALAMBOUS principal investigator
Cyprus University of Technology (Nursing Department)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactoferrin and Recombinant human erythropoietin in people with Anemia, run by Cyprus University of Technology at 2 sites in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas CHARALAMBOUS, PhD (99693478, andreas.charalambous@cut.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (time frame: Change from baseline at 2, 4, 6, 8, 10, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.