Lifemel Honey to Reduce Leucopenia During Chemotherapy

This study is not yet open for participant recruitment.

Verified by Rambam Health Care Campus, October 2005

First Received: October 20, 2005 No Changes Posted

Sponsor:	Rambam Health Care Campus
Collaborator:	zufglobus.com
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:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

zufglobus.com

Investigators

Principal Investigator:

Georgeta Fried, MD

Rambam Health Care Campus

More Information

No publications provided

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

Keywords provided by Rambam Health Care Campus:

breast cancer
honey
myelosuppression
chemotherapy

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Hematologic Diseases

Breast Neoplasms
Leukocyte Disorders
Leukopenia
Breast Diseases

ClinicalTrials.gov processed this record on November 30, 2009