Lifemel Honey to Reduce Leucopenia During Chemotherapy - Tabular View

Tracking Information

First Received Date ^ICMJE

October 20, 2005

Last Updated Date

October 20, 2005

Start Date ^ICMJE

November 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Prevention of myelotoxicity-every week during chemotherapy.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Lifemel Honey to Reduce Leucopenia During Chemotherapy

Official Title ^ICMJE

Lifemel Honey During Adjuvant Chemotherapy for Breast Cancer Patients to Prevent Leucopenia

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Behavioral: Lifemel honey intake every day

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

none

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Georgeta Fried, MD

972-4-8543018

g_fried@rambam.health.gov.il

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00243165

Responsible Party

Study ID Numbers ^ICMJE

LifemelCTIL

Study Sponsor ^ICMJE

Rambam Health Care Campus

Collaborators ^ICMJE

zufglobus.com

Investigators ^ICMJE

Principal Investigator:

Georgeta Fried, MD

Rambam Health Care Campus

Information Provided By

Rambam Health Care Campus

Verification Date

October 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP