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

This study is currently recruiting participants.
Verified by Ziv Hospital, September 2007

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

U.S. FDA Resources

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

Further study details as provided by Ziv Hospital:

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients below 18 years old

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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    
  More Information

Publications:

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

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

Study placed in the following topic categories:
Thrombocytopenia
Leukopenia

ClinicalTrials.gov processed this record on August 27, 2008




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