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Garlic in Patients With Febrile Neutropenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00247039
Recruitment Status : Unknown
Verified July 2013 by Moshe Gatt, Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : November 1, 2005
Last Update Posted : July 8, 2013
Information provided by (Responsible Party):
Moshe Gatt, Hadassah Medical Organization

Brief Summary:
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 or disease Intervention/treatment Phase
Chemotherapy Neutropenia Dietary Supplement: Solgar Israel Other: Placebo capsules Phase 1 Phase 2

Detailed Description:
Patients eligible are randomized to receive placebo or garlic capsules after chemotherapy course and until leukocyte recovery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Controlled Study to Determine The Clinical Efficacy Of Garlic Compounds In Patients With Chemotherapy Related Febrile Neutropenia
Study Start Date : June 2006
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Garlic extract
Garlic extract capsules
Dietary Supplement: Solgar Israel
Dietary Supplement: garlic natural compound one pill, 450 mg active garlic extract (Solgar, Israel), bid.

Placebo Comparator: Placebo
Placebo capsules
Other: Placebo capsules
placebo capsules

Primary Outcome Measures :
  1. Time to fever and beginning of empiric antibiotic treatment. [ Time Frame: 0-45 days post chemotherapy ]

Secondary Outcome Measures :
  1. Documented and culture positive infections. [ Time Frame: as above ]
  2. Kind of infectious organisms and sensitivity to medicines. [ Time Frame: as above ]
  3. Length of infection [ Time Frame: as above ]
  4. Use of growth factors. [ Time Frame: as above ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00247039

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Contact: moshe e gatt, dr 972-50-5172333

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Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: arik Tzukert, DMD    00 972 2 6777572   
Principal Investigator: moshe e gatt, dr         
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: moshe e gatt, dr Hadassah Medical Organization

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Moshe Gatt, Dr. Moshe Gatt, Hadassah Medical Organization Identifier: NCT00247039    
Other Study ID Numbers: 384 gar 1- HMO-CTIL
GAR1 ( Other Grant/Funding Number: Dunsky grant for cancer research )
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: July 8, 2013
Last Verified: July 2013
Keywords provided by Moshe Gatt, Hadassah Medical Organization:
Additional relevant MeSH terms:
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Febrile Neutropenia
Leukocyte Disorders
Hematologic Diseases