Lifemel Honey to Reduce Leucopenia During Chemotherapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Rambam Health Care Campus.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Rambam Health Care Campus
Collaborator:
Zuf Globus Laboratories Ltd.
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00243165
First received: October 20, 2005
Last updated: December 4, 2009
Last verified: October 2005
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 20, 2005 | ||||
| Last Updated Date | December 4, 2009 | ||||
| Start Date ICMJE | November 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Prevention of myelotoxicity-every week during chemotherapy. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00243165 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Lifemel Honey to Reduce Leucopenia During Chemotherapy | ||||
| Official Title ICMJE | Lifemel Honey During Adjuvant Chemotherapy for Breast Cancer Patients to Prevent Leucopenia | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
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| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE | Behavioral: Lifemel honey intake every day | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00243165 | ||||
| Other Study ID Numbers ICMJE | LifemelCTIL | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Rambam Health Care Campus | ||||
| Collaborators ICMJE | Zuf Globus Laboratories Ltd. | ||||
| Investigators ICMJE |
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| Information Provided By | Rambam Health Care Campus | ||||
| Verification Date | October 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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