Garlic in Patients With Febrile Neutropenia

NCT00247039 | Unknown Phase 1 DMC

• 2 other identifiers: 384 gar 1- HMO-CTILGAR1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy; Neutropenia

Keywords

neutropenia; fever; garlic; infection

Outcome Measures

Primary Outcomes (1)

• Time to fever and beginning of empiric antibiotic treatment.

  0-45 days post chemotherapy

Secondary Outcomes (4)

• 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

Study Arms (2)

Garlic extract

EXPERIMENTAL

Garlic extract capsules

Dietary Supplement: Solgar Israel

Placebo

PLACEBO COMPARATOR

Placebo capsules

Other: Placebo capsules

Interventions

Solgar Israel DIETARY_SUPPLEMENT

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

Garlic extract

Placebo capsules OTHER

placebo capsules

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 26036623 DERIVED

MeSH Terms

Conditions

Neutropenia; Fever; Infections

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• moshe e gatt, dr

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

moshe e gatt, dr

CONTACT

972-50-5172333; dr.mgatt@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Moshe Gatt

Study Record Dates

• First Submitted: October 31, 2005
• First Posted: November 1, 2005
• Study Start: June 1, 2006
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 8, 2013

Record last verified: 2013-07

Locations

IL (1)