Back to resultsLIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy (LEO)
Primary Purpose
Neutropenia, Adverse Event
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lifemel
Sponsored by
About this trial
This is an interventional supportive care trial for Neutropenia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifemel
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04562922
Brief Title
LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy
Acronym
LEO
Official Title
LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 11, 2013 (Actual)
Primary Completion Date
May 26, 2014 (Actual)
Study Completion Date
April 4, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VitalMel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia, Adverse Event
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifemel
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lifemel
Primary Outcome Measure Information:
Title
Neutropenia
Description
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.
Time Frame
Three months for each patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Pietro Sponghini
Organizational Affiliation
Department of Oncology, A.O.U. Maggiore della Carità, Novara, Italy.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
9095563
Citation
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.
Results Reference
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PubMed Identifier
31830663
Citation
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.
Results Reference
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PubMed Identifier
17303914
Citation
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.
Results Reference
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LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy
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