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Lifemel Honey to Reduce Leucopenia During Chemotherapy

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lifemel honey intake every day
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer, honey, myelosuppression, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: breast cancer patient treated with adjuvant chemotherapy PS = 2 or less Exclusion Criteria: none

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Prevention of myelotoxicity-every week during chemotherapy.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 20, 2005
    Last Updated
    December 4, 2009
    Sponsor
    Rambam Health Care Campus
    Collaborators
    Zuf Globus Laboratories Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00243165
    Brief Title
    Lifemel Honey to Reduce Leucopenia During Chemotherapy
    Official Title
    Lifemel Honey During Adjuvant Chemotherapy for Breast Cancer Patients to Prevent Leucopenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2005
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Rambam Health Care Campus
    Collaborators
    Zuf Globus Laboratories Ltd.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    breast cancer, honey, myelosuppression, chemotherapy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifemel honey intake every day
    Primary Outcome Measure Information:
    Title
    Prevention of myelotoxicity-every week during chemotherapy.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: breast cancer patient treated with adjuvant chemotherapy PS = 2 or less Exclusion Criteria: none
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Georgeta Fried, MD
    Phone
    972-4-8543018
    Email
    g_fried@rambam.health.gov.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Georgeta Fried, MD
    Organizational Affiliation
    Rambam Health Care Campus
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Lifemel Honey to Reduce Leucopenia During Chemotherapy

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