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

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00247026

Collaborator

(none)

Enrollment

Location

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome	Drug: curcumin; coenzyme q10	Phase 1/Phase 2

Study Design

Study Type:

Interventional

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

Study Start Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

major hematologic improvement in any lineage []

Secondary Outcome Measures

Time to disease progression []
Overall and progression-free survival []
Cytogenetic response []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.