NCT00524797

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
Last Updated

September 5, 2007

Status Verified

September 1, 2007

First QC Date

September 2, 2007

Last Update Submit

September 2, 2007

Conditions

Myelosuppression

Keywords

Myelosuppression,chemotherapeutic agents,leucopenia,thrombocytopenia,Profonycia

Study Arms (1)

Main

ACTIVE COMPARATOR

50 patients will receive Profonycia 5 gr/day PO for 7 days

Dietary Supplement: Profonycia

Interventions

ProfonyciaDIETARY_SUPPLEMENT
Main

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients below 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oncology Unit, Ziv MC

Safed, 13110, Israel

RECRUITING

Oncology Unit

Safed, 13110, Israel

NOT YET RECRUITING

Related 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. doi: 10.1385/MO:23:4:549.

    PMID: 17303914BACKGROUND

MeSH Terms

Conditions

LeukopeniaThrombocytopenia

Condition Hierarchy (Ancestors)

CytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersBlood Platelet Disorders

Study Officials

  • Zidan Jamal, Prof

    Ziv MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zidan Jamal, Prof

CONTACT

+972 4 6828951

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 2, 2007

First Posted

September 5, 2007

Study Start

September 1, 2007

Last Updated

September 5, 2007

Record last verified: 2007-09

Locations

IL(2)