Lifemel Honey to Reduce Leucopenia During Chemotherapy | NCT00243165

Studies
Lifemel Honey to Reduce Leucopenia During Chemotherapy

NCT00243165

Sponsor

Rambam Health Care Campus

Status

Unknown status

Last Update Posted

Dec 7, 2009Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Lifemel honey intake every day

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 20, 2005

First Submission Date that Met QC Criteria

Oct 20, 2005

First Posted Date

Oct 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2009

Last Update Posted Date

Dec 7, 2009Estimated

Name	Class
Zuf Globus Laboratories Ltd.	OTHER

Description Module

Brief Summary

This study will include 60 patients with early breast cancer referred to receive adjuvant chemotherapy with AC ( adriamycin- cyclophosphamide) or CAF ( adriamycin- cyclophosphamide- 5- fluorouracil ) combinations. These patients will receive every day one spoon of Lifemel honey or regular honey ( double blind)- during the adjuvant chemotherapy .Every week a WBC count will be performed in order to record the influence of Lifemel on myelotoxicity.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
Lifemel honey intake every day	Behavioral

Measure	Description	Time Frame
Prevention of myelotoxicity-every week during chemotherapy.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

breast cancer patient treated with adjuvant chemotherapy
PS = 2 or less

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Georgeta Fried, MD	Contact	972-4-8543018		g_fried@rambam.health.gov.il

Overall Officials

Name	Affiliation	Role
Georgeta Fried, MD	Rambam Health Care Campus	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided