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Lifemel Honey to Reduce Leucopenia During Chemotherapy

NCT ID: NCT00243165

Last Updated: 2009-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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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

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Conditions

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Breast Cancer

Keywords

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breast cancer honey myelosuppression chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Lifemel honey intake every day

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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Zuf Globus Laboratories Ltd.

OTHER

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role lead

Principal Investigators

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Georgeta Fried, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Central Contacts

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Georgeta Fried, MD

Role: CONTACT

Phone: 972-4-8543018

Email: [email protected]

Other Identifiers

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LifemelCTIL

Identifier Type: -

Identifier Source: org_study_id