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

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.

Study Overview

• Status: Completed
• Conditions: Neutropenia; Adverse Event
• Intervention / Treatment: Dietary supplement: Lifemel

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Three months for each patient

Collaborators and Investigators

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

Publications and helpful links

General 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.
• 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. doi: 10.1385/MO:23:4:549.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2013
• Primary Completion (Actual): May 26, 2014
• Study Completion (Actual): April 4, 2016

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia
• Other Study ID Numbers: LEO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No