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

VitalMel

Status and phase: Completed; Phase 2

Conditions: Adverse Event; Neutropenia

Treatments: Dietary Supplement: Lifemel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04562922

LEO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Lifemel

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Lifemel