Lifemel Honey to Reduce Leucopenia During Chemotherapy
Sponsor
Rambam Health Care Campus (Other)
Overall Status
Unknown status
CT.gov ID
NCT00243165
Collaborator
Zuf Globus Laboratories Ltd. (Other)
60
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Official Title:
Lifemel Honey During Adjuvant Chemotherapy for Breast Cancer Patients to Prevent Leucopenia
Study Start Date
:
Nov 1, 2005
Outcome Measures
Primary Outcome Measures
- Prevention of myelotoxicity-every week during chemotherapy. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
breast cancer patient treated with adjuvant chemotherapy
-
PS = 2 or less
Exclusion Criteria:
- none
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Rambam Health Care Campus
- Zuf Globus Laboratories Ltd.
Investigators
- Principal Investigator: Georgeta Fried, MD, Rambam Health Care Campus
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00243165
Other Study ID Numbers:
- LifemelCTIL
First Posted:
Oct 21, 2005
Last Update Posted:
Dec 7, 2009
Last Verified:
Oct 1, 2005
Keywords provided by ,
,
Additional relevant MeSH terms: