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The Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00247026
Recruitment Status : Withdrawn (No funding)
First Posted : November 1, 2005
Last Update Posted : April 11, 2007
Sponsor:
Information provided by:
Hadassah Medical Organization

Study Description
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Brief Summary:
To determine the clinical effects of coenzyme Q10 and Curcumin in improving the cytopenias of patients with myelodysplastic syndromes. we propose to explore the efficacy of the natural compounds curcumin and CoQ10 in MDS because these two agents possess many of the effects that are desirable in MDS.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: curcumin; coenzyme q10 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Determine the Clinical Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes
Study Start Date : April 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. major hematologic improvement in any lineage

Secondary Outcome Measures :
  1. Time to disease progression
  2. Overall and progression-free survival
  3. Cytogenetic response

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MDS patients with RA, RARS or RAEB will be eligible for treatment with CoQ10 as long as their IPSS score ≤ 1.5.

Exclusion Criteria:

  • Pregnant women and nursing women will be excluded.
  • History of clinically significant liver or kidney disease.
  • ECOG>2
  • IPSS score >1.5
  • Poorly controlled diabetes mellitus, hypertension, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to the protocol.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247026


Locations
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Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: moshe e gatt, dr Hadassah Medical Organization
More Information
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ClinicalTrials.gov Identifier: NCT00247026    
Other Study ID Numbers: 385-mds 1-HMO-CTIL
mds 1
First Posted: November 1, 2005    Key Record Dates
Last Update Posted: April 11, 2007
Last Verified: April 2007
Keywords provided by Hadassah Medical Organization:
myelodysplasia
curcumin
coenzyme Q10
cytopenia
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Ubiquinone
Coenzyme Q10
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Micronutrients
Vitamins