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| Sponsored by: |
Ziv Hospital |
| Information provided by: | Ziv Hospital |
| ClinicalTrials.gov Identifier: | NCT00524797 |
Purpose
Myelosuppression (bone marrow suppression) is the most important toxic side effect of the majority of chemotherapeutic agents and typically is the dose limiting factor. Death occurring after chemotherapy usually results either from infection related to drug induced leucopenia or from bleeding related to thrombocytopenia. Colony stimulating factors (CSFs) are widely used in the treatment of chemotherapy induced neutropenia. The same Erythropoetines are used in the treatment of chemotherapy induced anemia. Both treatments are expensive and have several side effects.
In our previous stud (1) we found a special kind of honey: Life-Mel Honey to reduce the incidence of chemotherapy induced pancytopenia and improving quality of life.
The aim of the recent planed study is to provide prophylactic and protective treatment against neutropenia reducing the need for secondary CSF administration in patients receiving chemotherapy along with a natural and non expensive honey: Profonycia.
This honey which is expressed in Kibutz Shamir in Upper Galliee seems promising and easy for administration: given 5 gr/day per os for 7 days from the administration of chemotherapy.
| Condition | Intervention |
|
Myelosuppression |
Dietary Supplement: Profonycia |
| Study Type: | Interventional |
| Study Design: | Prevention, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Profonycia - Honey for Improving Quality of Patient's Life Receiving Chemotherapy |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2007 |
| Arms | Assigned Interventions |
|
Main: Active Comparator
50 patients will receive Profonycia 5 gr/day PO for 7 days
|
Dietary Supplement: Profonycia |
Eligibility
| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients 18 years old or elder receiving chemotherapy 1/2-3 weeks
Exclusion Criteria:
Patients below 18 years old
Contacts and Locations| Contact: Zidan Jamal, Prof | +972 4 6828951 |
| Israel | |||||
| Oncology Unit, Ziv MC | Recruiting | ||||
| Safed, Israel, 13110 | |||||
| Contact: Zidan Jamal, Prof +972 4 682 8951 | |||||
| Principal Investigator: Zidan Jamal, Prof | |||||
| Sub-Investigator: Lika Chetber, MD | |||||
| Sub-Investigator: Amira Avzach | |||||
| Oncology Unit | Not yet recruiting | ||||
| Safed, Israel, 13110 | |||||
| Contact: Jamal Zidan, Prof + 972 4 6828951 | |||||
| Ziv Hospital |
| Principal Investigator: | Zidan Jamal, Prof | Ziv MC |
More Information
| Study ID Numbers: | HP 7-260 S |
| First Received: | September 2, 2007 |
| Last Updated: | September 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00524797 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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