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Profonycia - Honey for Improving Quality of Patient's Life Receiving Chemotherapy

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ClinicalTrials.gov Identifier: NCT00524797
Recruitment Status : Unknown
Verified September 2007 by Ziv Hospital.
Recruitment status was:  Recruiting
First Posted : September 5, 2007
Last Update Posted : September 5, 2007
Sponsor:
Information provided by:
Ziv Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Myelosuppression Dietary Supplement: Profonycia Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Profonycia - Honey for Improving Quality of Patient's Life Receiving Chemotherapy
Study Start Date : September 2007

Arm Intervention/treatment
Active Comparator: Main
50 patients will receive Profonycia 5 gr/day PO for 7 days
Dietary Supplement: Profonycia




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients 18 years old or elder receiving chemotherapy 1/2-3 weeks

Exclusion Criteria:

Patients below 18 years old


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00524797


Contacts
Contact: Zidan Jamal, Prof +972 4 6828951

Locations
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      
Sponsors and Collaborators
Ziv Hospital
Investigators
Principal Investigator: Zidan Jamal, Prof Ziv MC

Publications:
ClinicalTrials.gov Identifier: NCT00524797     History of Changes
Other Study ID Numbers: HP 7-260 S
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: September 5, 2007
Last Verified: September 2007

Keywords provided by Ziv Hospital:
Myelosuppression,
chemotherapeutic agents,
leucopenia,
thrombocytopenia,
Profonycia