Lifemel Honey to Reduce Leucopenia During Chemotherapy
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lifemel honey intake every day
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer, honey, myelosuppression, chemotherapy
Eligibility Criteria
Inclusion Criteria: breast cancer patient treated with adjuvant chemotherapy PS = 2 or less Exclusion Criteria: none
Sites / Locations
Outcomes
Primary Outcome Measures
Prevention of myelotoxicity-every week during chemotherapy.
Secondary Outcome Measures
Full Information
NCT ID
NCT00243165
First Posted
October 20, 2005
Last Updated
December 4, 2009
Sponsor
Rambam Health Care Campus
Collaborators
Zuf Globus Laboratories Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00243165
Brief Title
Lifemel Honey to Reduce Leucopenia During Chemotherapy
Official Title
Lifemel Honey During Adjuvant Chemotherapy for Breast Cancer Patients to Prevent Leucopenia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2005
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rambam Health Care Campus
Collaborators
Zuf Globus Laboratories Ltd.
4. Oversight
5. Study Description
Brief Summary
This study will include 60 patients with early breast cancer referred to receive adjuvant chemotherapy with AC ( adriamycin- cyclophosphamide) or CAF ( adriamycin- cyclophosphamide- 5- fluorouracil ) combinations. These patients will receive every day one spoon of Lifemel honey or regular honey ( double blind)- during the adjuvant chemotherapy .Every week a WBC count will be performed in order to record the influence of Lifemel on myelotoxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, honey, myelosuppression, chemotherapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Lifemel honey intake every day
Primary Outcome Measure Information:
Title
Prevention of myelotoxicity-every week during chemotherapy.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
breast cancer patient treated with adjuvant chemotherapy
PS = 2 or less
Exclusion Criteria:
none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georgeta Fried, MD
Phone
972-4-8543018
Email
g_fried@rambam.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgeta Fried, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Lifemel Honey to Reduce Leucopenia During Chemotherapy
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