LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy (LEO)

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ClinicalTrials.gov Identifier: NCT04562922

Recruitment Status : Completed

First Posted : September 24, 2020

Last Update Posted : September 24, 2020

Sponsor:

Information provided by (Responsible Party):

VitalMel

Study Description

Brief 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. Secondary endpoints of LEO trial were assessing impact of LifeMel in preventing anaemia and thrombocytopenia.

Condition or disease	Intervention/treatment	Phase
Neutropenia Adverse Event	Dietary Supplement: Lifemel	Phase 2

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

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	39 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy
Actual Study Start Date :	November 11, 2013
Actual Primary Completion Date :	May 26, 2014
Actual Study Completion Date :	April 4, 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Cyclic neutropenia

Genetic and Rare Diseases Information Center resources: Granulocytopenia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lifemel 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.	Dietary Supplement: Lifemel

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562922

Sponsors and Collaborators

VitalMel

Investigators

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Principal Investigator:	Andrea Pietro Sponghini	Department of Oncology, A.O.U. Maggiore della Carità, Novara, Italy.

More Information

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.

Abdel-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. Review.

Zidan 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.

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Responsible Party:	VitalMel
ClinicalTrials.gov Identifier:	NCT04562922
Other Study ID Numbers:	LEO
First Posted:	September 24, 2020 Key Record Dates
Last Update Posted:	September 24, 2020
Last Verified:	September 2020

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Neutropenia Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases

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