ChemotherapyPhase 1/2NCT00247039
Garlic in Patients With Febrile Neutropenia
A Phase 1/2 study testing Solgar Israel in people with Chemotherapy and Neutropenia, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chemotherapy, Neutropenia
- What is being tested?
- Solgar Israel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2006to Aug 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
arik Tzukert, DMD, 00 972 2 6777572, lhadas@hadassah.org.il
moshe e gatt, dr
About this study
Official title: A Controlled Study to Determine The Clinical Efficacy Of Garlic Compounds In Patients With Chemotherapy Related Febrile Neutropenia
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.
Read the detailed description
Patients eligible are randomized to receive placebo or garlic capsules after chemotherapy course and until leukocyte recovery.
- Conditions
- Chemotherapy, Neutropenia
- Being tested
- Solgar Israel, Placebo capsules
- Keywords
- neutropenia, fever, garlic, infection
- Medical subject headings
- Neutropenia, Fever, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solgar IsraelDietary supplement
Dietary Supplement: garlic natural compound one pill, 450 mg active garlic extract (Solgar, Israel), bid.
Placebo capsulesOther
placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Garlic extract | Experimental | Garlic extract capsules Receives: Dietary Supplement: Solgar Israel |
| Placebo | Placebo comparator | Placebo capsules Receives: Other: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to fever and beginning of empiric antibiotic treatment.
Measured: 0-45 days post chemotherapy
Secondary outcomes (4)
Documented and culture positive infections.
Measured: as above
Kind of infectious organisms and sensitivity to medicines.
Measured: as above
Length of infection
Measured: as above
Use of growth factors.
Measured: as above
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startJun 2006
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChemotherapyStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moshe Gatt, Hadassah Medical Organization
- Investigators
- moshe e gatt, dr, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247039
- Sponsor's protocol ID
- 384 gar 1- HMO-CTIL
- Other IDs
- GAR1
- Status last verified
- Jul 2013
- First submitted
- 31 Oct 2005
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26036623
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study to Determine The Clinical Efficacy Of Garlic Compounds In Patients With Chemotherapy Related Febrile Neutropenia
- ClinicalTrials.gov ID
- NCT00247039
- Acronym / sponsor ID
- 384 gar 1- HMO-CTIL
- Conditions
- Chemotherapy, Neutropenia
- Keywords
- neutropenia, fever, garlic, infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 1 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Garlic extract | Experimental | Dietary Supplement: Solgar IsraelGarlic extract capsules |
| Placebo | Placebo comparator | Other: Placebo capsulesPlacebo capsules |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solgar IsraelDietary Supplement: garlic natural compound one pill, 450 mg active garlic extract (Solgar, Israel), bid. | Dietary supplement | Garlic extract |
| Placebo capsulesplacebo capsules | Other | Placebo |
Primary outcome
Time to fever and beginning of empiric antibiotic treatment.
Time frame: 0-45 days post chemotherapy
4 secondary outcomes
Documented and culture positive infections.
Time frame: as above
Kind of infectious organisms and sensitivity to medicines.
Time frame: as above
Length of infection
Time frame: as above
Use of growth factors.
Time frame: as above
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
- Derived from this study: PubMed 26036623Gatt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
moshe e gatt, dr principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Solgar Israel in people with Chemotherapy and Neutropenia, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact moshe e gatt, dr (972-50-5172333, dr.mgatt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to fever and beginning of empiric antibiotic treatment. (time frame: 0-45 days post chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00247039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2013.