- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00243165
Lifemel Honey to Reduce Leucopenia During Chemotherapy
December 4, 2009 updated by: Rambam Health Care Campus
Lifemel Honey During Adjuvant Chemotherapy for Breast Cancer Patients to Prevent Leucopenia
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Georgeta Fried, MD
- Phone Number: 972-4-8543018
- Email: g_fried@rambam.health.gov.il
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- breast cancer patient treated with adjuvant chemotherapy
- PS = 2 or less
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Prevention of myelotoxicity-every week during chemotherapy.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Georgeta Fried, MD, Rambam Health Care Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Study Registration Dates
First Submitted
October 20, 2005
First Submitted That Met QC Criteria
October 20, 2005
First Posted (Estimate)
October 21, 2005
Study Record Updates
Last Update Posted (Estimate)
December 7, 2009
Last Update Submitted That Met QC Criteria
December 4, 2009
Last Verified
October 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LifemelCTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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