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

First Received on October 20, 2005. Last Updated on December 4, 2009 History of Changes

Sponsor:	Rambam Health Care Campus
Collaborator:	Zuf Globus Laboratories Ltd.
Information provided by:	Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT00243165

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 II

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

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 February 12, 2012