Chemotherapy, Neutropenia
Conditions
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 Supplement: garlic natural compound one pill, 450 mg active garlic extract (Solgar, Israel), bid.
placebo capsules
Sponsors
Study design
Eligibility
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
| Measure | Time frame |
|---|---|
| Time to fever and beginning of empiric antibiotic treatment. | 0-45 days post chemotherapy |
Secondary
| Measure | 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 |
Countries
Israel