Garlic in Patients With Febrile Neutropenia

Neutropenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00247039
• Other study ID #: 384 gar 1- HMO-CTIL
• Secondary ID: GAR1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 31, 2005
• Last updated: July 4, 2013
• Start date: June 2006
• Est. completion date: August 2013

Study information

• Verified date: July 2013
• Source: Hadassah Medical Organization
• Contact: moshe e gatt, dr
• Phone: 972-50-5172333
• Email: dr.mgatt[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chemotherapy
• Febrile Neutropenia
• Neutropenia

Intervention

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

Other:
• Placebo capsules
placebo capsules

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to fever and beginning of empiric antibiotic treatment.		0-45 days post chemotherapy	No
Secondary	Documented and culture positive infections.		as above	No
Secondary	Kind of infectious organisms and sensitivity to medicines.		as above	No
Secondary	Length of infection		as above	No
Secondary	Use of growth factors.		as above	No