NCT00247026

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
1.4 years until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
Last Updated

April 11, 2007

Status Verified

April 1, 2007

First QC Date

October 31, 2005

Last Update Submit

April 10, 2007

Conditions

Myelodysplastic Syndrome

Keywords

myelodysplasiacurcumincoenzyme Q10cytopenia

Outcome Measures

Primary Outcomes (1)

  • major hematologic improvement in any lineage

Secondary Outcomes (3)

  • Time to disease progression

  • Overall and progression-free survival

  • Cytogenetic response

Interventions

curcumin; coenzyme q10DRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Myelodysplastic SyndromesAnemia, Refractory, with Excess of BlastsCytopenia

Interventions

Curcumincoenzyme Q10

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesAnemia, RefractoryAnemia

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • moshe e gatt, dr

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 1, 2005

Study Start

April 1, 2007

Last Updated

April 11, 2007

Record last verified: 2007-04

Locations

IL(1)