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Lifemel Honey to Reduce Leucopenia During Chemotherapy

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ClinicalTrials.gov Identifier: NCT00243165
Recruitment Status : Unknown
Verified October 2005 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : October 21, 2005
Last Update Posted : December 7, 2009
Sponsor:
Collaborator:
Zuf Globus Laboratories Ltd.
Information provided by:
Rambam Health Care Campus

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
Breast Cancer Behavioral: Lifemel honey intake every day Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. Prevention of myelotoxicity-every week during chemotherapy.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • breast cancer patient treated with adjuvant chemotherapy
  • PS = 2 or less

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243165


Contacts
Contact: Georgeta Fried, MD 972-4-8543018 g_fried@rambam.health.gov.il

Sponsors and Collaborators
Rambam Health Care Campus
Zuf Globus Laboratories Ltd.
Investigators
Principal Investigator: Georgeta Fried, MD Rambam Health Care Campus

ClinicalTrials.gov Identifier: NCT00243165     History of Changes
Other Study ID Numbers: LifemelCTIL
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: October 2005

Keywords provided by Rambam Health Care Campus:
breast cancer
honey
myelosuppression
chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Leukopenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Leukocyte Disorders
Hematologic Diseases