LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy

Neutropenia Clinical Trial

— LEO  

Official title:

LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04562922
• Other study ID #: LEO
• Status: Completed
• Phase: Phase 2
• Start date: November 11, 2013
• Est. completion date: April 4, 2016

Study information

• Verified date: September 2020
• Source: VitalMel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 4, 2016
• Est. primary completion date: May 26, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Event
• Neutropenia

Intervention

Dietary Supplement:
• Lifemel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VitalMel

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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