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

This study has been withdrawn prior to enrollment.
(No funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00247026
First Posted: November 1, 2005
Last Update Posted: April 11, 2007
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.
Information provided by:
Hadassah Medical Organization
  Purpose
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 Intervention Phase
Myelodysplastic Syndrome Drug: curcumin; coenzyme q10 Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • major hematologic improvement in any lineage

Secondary Outcome Measures:
  • Time to disease progression
  • Overall and progression-free survival
  • Cytogenetic response

Estimated Enrollment: 50
Study Start Date: April 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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
Information from the National Library of Medicine

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
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: moshe e gatt, dr Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00247026     History of Changes
Other Study ID Numbers: 385-mds 1-HMO-CTIL
mds 1
First Submitted: October 31, 2005
First Posted: November 1, 2005
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:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Curcumin
Coenzyme Q10
Ubiquinone
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
Growth Substances
Vitamins