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

NCT ID: NCT00524797

Last Updated: 2007-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myelosuppression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Main

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

Group Type ACTIVE_COMPARATOR

Profonycia

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Profonycia

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Patients below 18 years old
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ziv Hospital

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Zidan Jamal, Prof

Role: PRINCIPAL_INVESTIGATOR

Ziv MC

Locations

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Oncology Unit, Ziv MC

Safed, , Israel

Site Status RECRUITING

Oncology Unit

Safed, , Israel

Site Status NOT_YET_RECRUITING

Countries

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Israel

Central Contacts

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Zidan Jamal, Prof

Role: CONTACT

+972 4 6828951

Facility Contacts

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Zidan Jamal, Prof

Role: primary

+972 4 682 8951

Jamal Zidan, Prof

Role: primary

+ 972 4 6828951

References

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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.

Reference Type BACKGROUND
PMID: 17303914 (View on PubMed)

Other Identifiers

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HP 7-260 S

Identifier Type: -

Identifier Source: org_study_id