Chemotherapy | Garlic in Patients With Febrile Neutropenia
Chemotherapy research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:Solgar IsraelDietary Supplement: garlic natural compound one pill, 450 mg active garlic extract (Solgar, Israel), bid.
Other:Placebo capsulesplacebo capsules
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Garlic extractGarlic extract capsules
Start Date: June 2006
Completed Date: August 2013
Phase: Phase 1/Phase 2
Primary Outcome: Time to fever and beginning of empiric antibiotic treatment.
Secondary Outcome: Documented and culture positive infections.
Study sponsors, principal investigator, and references
Principal Investigator: moshe e gatt, dr
Lead Sponsor: Hadassah Medical Organization