Back to resultsThe Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes
Primary Purpose
Myelodysplastic Syndrome
Status
Withdrawn
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
curcumin; coenzyme q10
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring myelodysplasia, curcumin, coenzyme Q10, cytopenia
Eligibility 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.
Sites / Locations
- Hadassah Medical Organization
Outcomes
Primary Outcome Measures
major hematologic improvement in any lineage
Secondary Outcome Measures
Time to disease progression
Overall and progression-free survival
Cytogenetic response
Full Information
NCT ID
NCT00247026
First Posted
October 31, 2005
Last Updated
April 10, 2007
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00247026
Brief Title
The Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes
Official Title
A Pilot Study to Determine the Clinical Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
myelodysplasia, curcumin, coenzyme Q10, cytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
curcumin; coenzyme q10
Primary Outcome Measure Information:
Title
major hematologic improvement in any lineage
Secondary Outcome Measure Information:
Title
Time to disease progression
Title
Overall and progression-free survival
Title
Cytogenetic response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
moshe e gatt, dr
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes
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