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Completed

NCT Number: NCT04562922

LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy

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.

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Key information

Conditions

Neutropenia Adverse Event Agranulocytosis Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifemel

Dietary Supplement

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

VitalMel

Industry

Registry information

Acronym: LEO

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Sep 24, 2020
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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