Neutropenia Clinical Trial
— LEOOfficial title:
LIFEMEL Efficacy in Preventing Haematopoietic Toxicity in Patients Treated With Chemotherapy
NCT number | NCT04562922 |
Other study ID # | LEO |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | November 11, 2013 |
Est. completion date | April 4, 2016 |
Verified date | September 2020 |
Source | VitalMel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
VitalMel |
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
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 |
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