NCT00243165

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2005

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
Last Updated

December 7, 2009

Status Verified

October 1, 2005

First QC Date

October 20, 2005

Last Update Submit

December 4, 2009

Conditions

Breast Cancer

Keywords

breast cancerhoneymyelosuppressionchemotherapy

Outcome Measures

Primary Outcomes (1)

  • Prevention of myelotoxicity-every week during chemotherapy.

Interventions

Lifemel honey intake every dayBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Georgeta Fried, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgeta Fried, MD

CONTACT

972-4-8543018g_fried@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2005

First Posted

October 21, 2005

Study Start

November 1, 2005

Last Updated

December 7, 2009

Record last verified: 2005-10