Garlic in Patients With Febrile Neutropenia

Phase 1

• Conditions: Chemotherapy; Neutropenia
• Interventions: Dietary Supplement: Solgar Israel; Other: Placebo capsules

• Registration Number: NCT00247039
• Lead Sponsor: Hadassah Medical Organization

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.

Study Timeline

• Study First Submitted: 2005-10-31
• Study First Submitted QC: 2005-10-31
• Study First Posted: 2005-11-01
• Study Start: 2006-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-04
• Last Update Posted: 2013-07-08
• Primary Completion: 2013-08
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Garlic extract	Solgar Israel	Garlic extract capsules
Placebo	Placebo capsules	Placebo capsules

Primary Outcome Measures

Name	Time	Method
Time to fever and beginning of empiric antibiotic treatment.	0-45 days post chemotherapy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel