The Efficacy of Coenzyme Q10 And Curcumin in Patients Wit... | NCT00247026

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

NCT00247026

Sponsor

Hadassah Medical Organization

Status

Withdrawn

Last Update Posted

Apr 11, 2007Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Myelodysplastic Syndrome

Interventions

curcumin; coenzyme q10

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
mds 1

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No funding

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 31, 2005

First Submission Date that Met QC Criteria

Oct 31, 2005

First Posted Date

Nov 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2007

Last Update Posted Date

Apr 11, 2007Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
curcumin; coenzyme q10	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
major hematologic improvement in any lineage

Secondary Outcomes

Measure	Description	Time Frame
Time to disease progression
Overall and progression-free survival
Cytogenetic response

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
moshe e gatt, dr	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D009190	Myelodysplastic Syndromes
D000754	Anemia, Refractory, with Excess of Blasts
D000095542	Cytopenia

Ancestor Terms

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000753	Anemia, Refractory

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003474	Curcumin
C024989	coenzyme Q10

Ancestor Terms

ID	Term
D036381	Diarylheptanoids
D006536	Heptanes
D000473	Alkanes
D006839	Hydrocarbons, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided