Lifemel Honey to Reduce Leucopenia During Chemotherapy

NCT ID: NCT00243165

Last Updated: 2009-12-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Lifemel honey intake every day

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zuf Globus Laboratories Ltd.

OTHER

Sponsor Role: collaborator

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Principal Investigators

Georgeta Fried, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Central Contacts

Georgeta Fried, MD

Role: CONTACT

g_fried@rambam.health.gov.il

972-4-8543018

Other Identifiers

LifemelCTIL

Identifier Type: -

Identifier Source: org_study_id