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

Myelosuppression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00524797
• Other study ID #: HP 7-260 S
• Status: Recruiting
• Phase: N/A
• First received: September 2, 2007
• Last updated: September 2, 2007
• Start date: September 2007

Study information

• Verified date: September 2007
• Source: Ziv Hospital
• Contact: Zidan Jamal, Prof
• Phone: +972 4 6828951
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Patients below 18 years old

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myelosuppression

Intervention

Dietary Supplement:
• Profonycia

Locations

Country	Name	City	State
Israel	Oncology Unit	Safed
Israel	Oncology Unit, Ziv MC	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Zidan J, Shetver L, Gershuny A, Abzah A, Tamam S, Stein M, Friedman E. Prevention of chemotherapy-induced neutropenia by special honey intake. Med Oncol. 2006;23(4):549-52. — View Citation