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

Myelodysplastic Syndrome Clinical Trial

Official title:

A Pilot Study to Determine the Clinical Efficacy of Coenzyme Q10 And Curcumin in Patients With Myelodysplastic Syndromes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00247026
• Other study ID #: 385-mds 1-HMO-CTIL
• Secondary ID: mds 1
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: October 31, 2005
• Last updated: April 10, 2007
• Start date: April 2007

Study information

• Verified date: April 2007
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• curcumin; coenzyme q10

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major hematologic improvement in any lineage
Secondary	Time to disease progression
Secondary	Overall and progression-free survival
Secondary	Cytogenetic response