NeutropeniaPhase 2LEONCT04562922
LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy
A Phase 2 study testing Lifemel in people with Neutropenia and Adverse Event, run by VitalMel.
Trial summary
LEO trial was designed to assess the benefit of administering LifeMel to prevent myelotoxicity in patients affected by solid neoplasm undergoing antiblastic chemotherapy treatment at low to moderate risk of febrile neutropenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neutropenia, Adverse Event
- What is being tested?
- Lifemel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2013to 4 Apr 2016
- Phase
- Phase 2
- 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
- age >=18 years old
- histological or clinical diagnosis of solid neoplasia
- indication for chemotherapy treatment with regimens at moderate risk of neutropenia fever - duration of chemotherapy treatment more than 3 months
Who cannot join
- known intolerances to honey containing compounds
- decompensated diabetes or severe glucose intolerance
- diseases or therapies significantly affecting the neutrophil count
- concurrent use of G-CSF as primary or secondary prophylaxis in the study
About this study
LEO trial was designed to assess the benefit of administering LifeMel to prevent myelotoxicity in patients affected by solid neoplasm undergoing antiblastic chemotherapy treatment at low to moderate risk of febrile neutropenia. Secondary endpoints of LEO trial were assessing impact of LifeMel in preventing anaemia and thrombocytopenia.
Read the detailed description
The LEO trial was designed to assess the benefit of administering LifeMel, a honey from bees obtained using Zuf Globus Ltd technology, produced in Israel and listed by the Ministry of Health in Italy as a food supplement. This study aims to highlight a possible role of Lifemel in preventing neutropenic events, as well as reducing anaemia and thrombocytopenia following the administration of chemotherapy in patients with a histological or clinical diagnosis of solid neoplasia undergoing first-line chemotherapy.
- Conditions
- Neutropenia, Adverse Event
- Being tested
- Lifemel
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifemelDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Lifemel | Experimental | LifeMel is bee-honey obtained using Zuf Globus Ltd technology: it is produced in Israel and distributed by VitalMel in Italy. In Italy Ministry of Health has listed it as a food supplement.
Two tea spoons (5 g each) of honey were administered to subjects on each day of the chemotherapy treatment. Receives: Dietary Supplement: Lifemel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutropenia
Neutrophil count has been measured the same day or the day before starting every chemotherapy cycle and at expected nadir (between the 7th and 12th day after chemotherapy) in the first 3 months.
A patient was considered 'responder' if no episodes of neutropenia was observed during first 3 months of chemotherapy.
Measured: Three months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start11 Nov 2013
- Primary completion26 May 2014
- Study completion4 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NeutropeniaStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- VitalMel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Pietro Sponghini, Principal investigator, Department of Oncology, A.O.U. Maggiore della Carità, Novara, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562922
- Sponsor's protocol ID
- LEO
- Acronym
- LEO
- Status last verified
- Sep 2020
- First submitted
- 27 Aug 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
PubMed 9095563Abdel-Razeq H, Hashem H. Recent update in the pathogenesis and treatment of chemotherapy and cancer induced anemia. Crit Rev Oncol Hematol. 2020 Jan;145:102837. doi: 10.1016/j.critrevonc.2019.102837. Epub 2019 Nov 26.
PubMed 31830663Zidan J, Shetver L, Gershuny A, Abzah A, Tamam S, Stein M, Friedman E. Prevention of chemotherapy-induced neutropenia by special honey intake. Med Oncol. 2006;23(4):549-52. doi: 10.1385/MO:23:4:549.
PubMed 17303914
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT04562922
- Acronym / sponsor ID
- LEO / LEO
- Conditions
- Neutropenia, Adverse Event
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- VitalMelIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2013 (actual)
- Primary completion
- 26 May 2014 (actual)
- Study completion
- 4 Apr 2016 (actual)
- First posted
- 24 Sep 2020 (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.
LEO trial was designed to assess the benefit of administering LifeMel to prevent myelotoxicity in patients affected by solid neoplasm undergoing antiblastic chemotherapy treatment at low to moderate risk of febrile neutropenia. Secondary endpoints of LEO trial were assessing impact of LifeMel in preventing anaemia and thrombocytopenia.
Detailed description
The LEO trial was designed to assess the benefit of administering LifeMel, a honey from bees obtained using Zuf Globus Ltd technology, produced in Israel and listed by the Ministry of Health in Italy as a food supplement. This study aims to highlight a possible role of Lifemel in preventing neutropenic events, as well as reducing anaemia and thrombocytopenia following the administration of chemotherapy in patients with a histological or clinical diagnosis of solid neoplasia undergoing first-line chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifemel | Experimental | Dietary Supplement: LifemelLifeMel is bee-honey obtained using Zuf Globus Ltd technology: it is produced in Israel and distributed by VitalMel in Italy. In Italy Ministry of Health has listed it as a food supplement. Two tea spoons (5 g each) of honey were administered to subjects on each day of the chemotherapy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age >=18 years old
- histological or clinical diagnosis of solid neoplasia
- indication for chemotherapy treatment with regimens at moderate risk of neutropenia fever - duration of chemotherapy treatment more than 3 months
Key exclusion criteria (4 listed)
- known intolerances to honey containing compounds
- decompensated diabetes or severe glucose intolerance
- diseases or therapies significantly affecting the neutrophil count
- concurrent use of G-CSF as primary or secondary prophylaxis in the study
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 |
|---|---|---|
| Lifemel | Dietary supplement | Lifemel |
Primary outcome
Neutropenia
Time frame: Three months for each patient
Neutrophil count has been measured the same day or the day before starting every chemotherapy cycle and at expected nadir (between the 7th and 12th day after chemotherapy) in the first 3 months. A patient was considered 'responder' if no episodes of neutropenia was observed during first 3 months of chemotherapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Background: PubMed 9095563Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
- Background: PubMed 31830663Abdel-Razeq H, Hashem H. Recent update in the pathogenesis and treatment of chemotherapy and cancer induced anemia. Crit Rev Oncol Hematol. 2020 Jan;145:102837. doi: 10.1016/j.critrevonc.2019.102837. Epub 2019 Nov 26.
- Background: PubMed 17303914Zidan J, Shetver L, Gershuny A, Abzah A, Tamam S, Stein M, Friedman E. Prevention of chemotherapy-induced neutropenia by special honey intake. Med Oncol. 2006;23(4):549-52. doi: 10.1385/MO:23:4:549.
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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.
Andrea Pietro Sponghini principal investigator
Department of Oncology, A.O.U. Maggiore della Carità, Novara, Italy.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lifemel in people with Neutropenia and Adverse Event, run by VitalMel.
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 3 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: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutropenia (time frame: Three months for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04562922, which also lists 3 linked publications.
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 24 Sep 2020.