LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04562922

Acronym

LEO

Enrollment

Registered

2020-09-24

Start date

2013-11-11

Completion date

2016-04-04

Last updated

2020-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Event, Neutropenia

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.

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.

Interventions

DIETARY_SUPPLEMENTLifemel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Neutropenia	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026