Garlic in Patients With Febrile Neutropenia

This study is currently recruiting participants.

Verified by Hadassah Medical Organization, September 2006

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00247039

Purpose

To determine the clinical effects of garlic in preventing and treatment of patients with chemotherapy related febrile neutropenia.These patients have a very high incidence of infections which are not routinely covered by the standard empiric therapy. Adding a non- toxic and possibly effective therapy may reduce the risk for infections, synergize the empiric antibiotic treatment and may lessen the need for broader spectrum and more severe side effects.

Condition	Intervention	Phase
Chemotherapy Neutropenia	Drug: garlic natural compound	Phase I Phase II

MedlinePlus related topics: Fever

Drug Information available for: Allium sativum extract

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	A Controlled Study to Determine The Clinical Efficacy Of Garlic Compounds In Patients With Chemotherapy Related Febrile Neutropenia

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Time to fever and beginning of empiric antibiotic treatment.

Secondary Outcome Measures:

Documented and culture positive infections.
Kind of infectious organisms and sensitivity to medicines.
Length of infection
Use of growth factors.

Estimated Enrollment:	120
Study Start Date:	June 2006
Estimated Study Completion Date:	September 2007

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

FN patients expected to have at least 5 days or more of neutropenia will be eligible for treatment with garlic compounds
AST/ALT ≤ 3 times the upper limit of institutional laboratory normal.
Total bilirubin ≤ 2 times the upper limit of institutional laboratory normal.
BUN and creatinine should be ≤ 3 times the upper limit of institutional laboratory normal.
Newly diagnosed as well as previously treated patients will be eligible.

Exclusion Criteria:

History of clinically significant liver or kidney disease.
Patients on anti-coagulation therapy with Coumadin will be excluded because of the potential garlic interference with metabolism.
Patients receiving concomitant chemotherapeutic treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247039

Contacts

Contact: moshe e gatt, dr

972-50-7874854

gatt@md.huji.ac.il

Locations

Israel
Hadassah Medical Organization	Recruiting
jerusalem, Israel
Contact: arik Tzukert, DMD 00 972 2 6777572 lhadas@hadassah.org.il
Principal Investigator: moshe e gatt, dr

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

moshe e gatt, dr

Hadassah-Hebrew University Medical Center

More Information

Study ID Numbers:	384 gar 1- HMO-CTIL, gar 1
Study First Received:	October 31, 2005
Last Updated:	April 10, 2007
ClinicalTrials.gov Identifier:	NCT00247039
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

neutropenia
fever
garlic
infection

Study placed in the following topic categories:

Fever
Neutropenia
Hematologic Diseases
Agranulocytosis

Leukocyte Disorders
Leukopenia
Granulocytopenia

ClinicalTrials.gov processed this record on January 16, 2009