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Garlic in Patients With Febrile Neutropenia

H

Hadassah Medical Center

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Neutropenia
Chemotherapy

Treatments

Dietary Supplement: Solgar Israel
Other: Placebo capsules

Study type

Interventional

Funder types

Other

Identifiers

NCT00247039
384 gar 1- HMO-CTIL
GAR1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment

120 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

120 participants in 2 patient groups, including a placebo group

Garlic extract
Experimental group
Description:
Garlic extract capsules
Treatment:
Dietary Supplement: Solgar Israel
Placebo
Placebo Comparator group
Description:
Placebo capsules
Treatment:
Other: Placebo capsules

Trial contacts and locations

1

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Central trial contact

moshe e gatt, dr

Data sourced from clinicaltrials.gov

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