Garlic in Patients With Febrile Neutropenia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Moshe Gatt, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00247039
First received: October 31, 2005
Last updated: July 4, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Chemotherapy
Neutropenia
Dietary Supplement: Solgar Israel
Other: Placebo capsules
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Controlled Study to Determine The Clinical Efficacy Of Garlic Compounds In Patients With Chemotherapy Related Febrile Neutropenia

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Time to fever and beginning of empiric antibiotic treatment. [ Time Frame: 0-45 days post chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Documented and culture positive infections. [ Time Frame: as above ] [ Designated as safety issue: No ]
  • Kind of infectious organisms and sensitivity to medicines. [ Time Frame: as above ] [ Designated as safety issue: No ]
  • Length of infection [ Time Frame: as above ] [ Designated as safety issue: No ]
  • Use of growth factors. [ Time Frame: as above ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2006
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Garlic extract
Garlic extract capsules
Dietary Supplement: Solgar Israel
Dietary Supplement: garlic natural compound one pill, 450 mg active garlic extract (Solgar, Israel), bid.
Placebo Comparator: Placebo
Placebo capsules
Other: Placebo capsules
placebo capsules

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247039

Contacts
Contact: moshe e gatt, dr 972-50-5172333 dr.mgatt@gmail.com

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: arik Tzukert, DMD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: moshe e gatt, dr         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: moshe e gatt, dr Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Moshe Gatt, Dr. Moshe Gatt, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00247039     History of Changes
Other Study ID Numbers: 384 gar 1- HMO-CTIL, GAR1
Study First Received: October 31, 2005
Last Updated: July 4, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
neutropenia
fever
garlic
infection

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014