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Garlic in Patients With Febrile Neutropenia

A Controlled Study to Determine The Clinical Efficacy Of Garlic Compounds In Patients With Chemotherapy Related Febrile Neutropenia

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00247039
Enrollment
120
Registered
2005-11-01
Start date
2006-06-30
Completion date
2013-08-31
Last updated
2013-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy, Neutropenia

Keywords

neutropenia, fever, garlic, infection

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.

Detailed description

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

Interventions

DIETARY_SUPPLEMENTSolgar Israel

Dietary Supplement: garlic natural compound one pill, 450 mg active garlic extract (Solgar, Israel), bid.

OTHERPlacebo capsules

placebo capsules

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Time to fever and beginning of empiric antibiotic treatment.0-45 days post chemotherapy

Secondary

MeasureTime frame
Documented and culture positive infections.as above
Kind of infectious organisms and sensitivity to medicines.as above
Length of infectionas above
Use of growth factors.as above

Countries

Israel

Contacts

Primary Contactmoshe e gatt, dr
dr.mgatt@gmail.com972-50-5172333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026