Garlic in Patients With Febrile Neutropenia

Hadassah Medical Organization120 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

120

Conditions

Chemotherapy Neutropenia

Interventions

Solgar IsraelDIETARY_SUPPLEMENT

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

Placebo capsulesOTHER

placebo capsules

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

Outcomes

Primary Outcomes

Time to fever and beginning of empiric antibiotic treatment.

Time frame: 0-45 days post chemotherapy

Secondary Outcomes

Documented and culture positive infections.

Time frame: as above

Kind of infectious organisms and sensitivity to medicines.

Time frame: as above

Length of infection

Time frame: as above

Use of growth factors.

Time frame: as above

Central Contacts

moshe e gatt, dr

CONTACT

972-50-5172333 dr.mgatt@gmail.com

Data from ClinicalTrials.gov

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