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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Recruitment Status : Withdrawn (No funding)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

Tracking Information
First Submitted Date  ICMJE October 31, 2005
First Posted Date  ICMJE November 1, 2005
Last Update Posted Date April 11, 2007
Study Start Date  ICMJE April 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2005)
major hematologic improvement in any lineage
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00247026 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2006)
  • Time to disease progression
  • Overall and progression-free survival
  • Cytogenetic response
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2005)
  • • Time to disease progression
  • • Overall and progression-free survival
  • • Cytogenetic response
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes
Official Title  ICMJE A Pilot Study to Determine the Clinical Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myelodysplastic Syndrome
Intervention  ICMJE Drug: curcumin; coenzyme q10
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Enrollment  ICMJE
 (submitted: October 31, 2005)
50
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00247026
Other Study ID Numbers  ICMJE 385-mds 1-HMO-CTIL
mds 1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: moshe e gatt, dr Hadassah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP