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Lifemel Honey to Reduce Leucopenia During Chemotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Zuf Globus Laboratories Ltd.
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00243165
First received: October 20, 2005
Last updated: December 4, 2009
Last verified: October 2005
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Behavioral: Lifemel honey intake every day
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Lifemel Honey During Adjuvant Chemotherapy for Breast Cancer Patients to Prevent Leucopenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

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

Estimated Enrollment: 60
Study Start Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00243165     History of Changes
Other Study ID Numbers: LifemelCTIL
Study First Received: October 20, 2005
Last Updated: December 4, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on May 22, 2013