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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Ziv Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT00524797
First received: September 2, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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
Active Comparator: Main
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00524797     History of Changes
Other Study ID Numbers: HP 7-260 S
Study First Received: September 2, 2007
Last Updated: September 2, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on October 01, 2014