Garlic in Patients With Febrile Neutropenia

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

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

Conditions
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Neutropenia, Chemotherapy

Intervention / Treatment
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* Dietary Supplement: Solgar Israel
* Other: Placebo capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Garlic extract<br>Garlic extract capsules | Dietary Supplement: Solgar Israel<br>* Dietary Supplement: garlic natural compound one pill, 450 mg active garlic extract (Solgar, Israel), bid.<br>|
| Placebo Comparator: Placebo<br>Placebo capsules | Other: Placebo capsules<br>* placebo capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to fever and beginning of empiric antibiotic treatment. |  | 0-45 days post chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documented and culture positive infections. |  | as above | 
| Kind of infectious organisms and sensitivity to medicines. |  | as above | 
| Length of infection |  | as above | 
| Use of growth factors. |  | as above | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neutropenia, fever, garlic, infection