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, sinergize the empiric antibiotic treatment and may lessen the need for broader spectrum and more severe side effects.

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

Further study details as provided by Hadassah Medical Organization:

Primary Outcomes: •Time to fever and beginning of empiric antibiotic treatment.
Secondary Outcomes: • Documented and culture positive infections.; • Kind of infectious organisms and sensitivity to medicines.; • Length of infection; • Use of growth factors.
Expected Total Enrollment:  100

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00247039

moshe e gatt, dr      972-50-7874854    gatt@md.huji.ac.il

Israel
      Hadassah Medical Organization, Jerusalem,  Israel

Study chairs or principal investigators

moshe e gatt, dr,  Principal Investigator,  hadassah hebrew university medical center   

Study ID Numbers:  384 gar 1- HMO-CTIL; gar 1
Last Updated:  December 8, 2005
Record first received:  October 31, 2005
ClinicalTrials.gov Identifier:  NCT00247039
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-01-10