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

• Sponsor: Ziv Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00524797
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Arm: 1
• Patients Per Site: 25

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• 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: Sep 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Oncology Unit, Ziv MC	Safed		Israel	13110
2	Oncology Unit	Safed		Israel	13110

Sponsors and Collaborators

• Ziv Hospital

Investigators

• Principal Investigator: Zidan Jamal, Prof, Ziv MC

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00524797
• Other Study ID Numbers: HP 7-260 S
• First Posted: Sep 5, 2007
• Last Update Posted: Sep 5, 2007
• Last Verified: Sep 1, 2007

• Keywords provided by , ,: Myelosuppression,; chemotherapeutic agents,; leucopenia,; thrombocytopenia,; Profonycia

Study Results

No Results Posted as of Sep 5, 2007