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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00243165
Other study ID # LifemelCTIL
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received October 20, 2005
Last updated December 4, 2009
Start date November 2005

Study information

Verified date October 2005
Source Rambam Health Care Campus
Contact Georgeta Fried, MD
Phone 972-4-8543018
Email g_fried@rambam.health.gov.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- breast cancer patient treated with adjuvant chemotherapy

- PS = 2 or less

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Lifemel honey intake every day


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Rambam Health Care Campus Zuf Globus Laboratories Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary Prevention of myelotoxicity-every week during chemotherapy.
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