Back to resultsGarlic in Patients With Febrile Neutropenia
Primary Purpose
Chemotherapy, Neutropenia
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Solgar Israel
Placebo capsules
Sponsored by
About this trial
This is an interventional prevention trial for Chemotherapy focused on measuring neutropenia, fever, garlic, infection
Eligibility Criteria
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
Sites / Locations
- Hadassah Medical OrganizationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Garlic extract
Placebo
Arm Description
Garlic extract capsules
Placebo capsules
Outcomes
Primary Outcome Measures
Time to fever and beginning of empiric antibiotic treatment.
Secondary Outcome Measures
Documented and culture positive infections.
Kind of infectious organisms and sensitivity to medicines.
Length of infection
Use of growth factors.
Full Information
NCT ID
NCT00247039
First Posted
October 31, 2005
Last Updated
July 4, 2013
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00247039
Brief Title
Garlic in Patients With Febrile Neutropenia
Official Title
A Controlled Study to Determine The Clinical Efficacy Of Garlic Compounds In Patients With Chemotherapy Related Febrile Neutropenia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy, Neutropenia
Keywords
neutropenia, fever, garlic, infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Garlic extract
Arm Type
Experimental
Arm Description
Garlic extract capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Solgar Israel
Intervention Description
Dietary Supplement: garlic natural compound one pill, 450 mg active garlic extract (Solgar, Israel), bid.
Intervention Type
Other
Intervention Name(s)
Placebo capsules
Intervention Description
placebo capsules
Primary Outcome Measure Information:
Title
Time to fever and beginning of empiric antibiotic treatment.
Time Frame
0-45 days post chemotherapy
Secondary Outcome Measure Information:
Title
Documented and culture positive infections.
Time Frame
as above
Title
Kind of infectious organisms and sensitivity to medicines.
Time Frame
as above
Title
Length of infection
Time Frame
as above
Title
Use of growth factors.
Time Frame
as above
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
moshe e gatt, dr
Phone
972-50-5172333
Email
dr.mgatt@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
moshe e gatt, dr
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
arik Tzukert, DMD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
moshe e gatt, dr
12. IPD Sharing Statement
Citations:
PubMed Identifier
26036623
Citation
Gatt ME, Strahilevitz J, Sharon N, Lavie D, Goldschmidt N, Kalish Y, Gural A, Paltiel OB. A Randomized Controlled Study to Determine the Efficacy of Garlic Compounds in Patients With Hematological Malignancies at Risk for Chemotherapy-Related Febrile Neutropenia. Integr Cancer Ther. 2015 Sep;14(5):428-35. doi: 10.1177/1534735415588928. Epub 2015 Jun 2.
Results Reference
derived
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Garlic in Patients With Febrile Neutropenia
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