The Effect of Combination Ultra Q10 and L-carnitine on the Course of Myelodysplastic Syndrome

Myelodysplastic Syndrome Clinical Trial

Official title:

The Effect of the Nutritional Supplements: Ultra Q10 and L-carnitine on the Clinical Course of Myelodysplastic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02042482
• Other study ID #: KMC01-35-12
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 15, 2014
• Last updated: January 19, 2014
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: January 2014
• Source: Kaplan Medical Center
• Contact: Kalman Filanovsky, , MD
• Phone: 972-89441747
• Email: kalmanph[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is determine whether combination Q10 , L-carnitine and multivitamin and mineral complex is effective in treatment of patients with low and intermidiate1-2 risk Myelodysplastic syndrome

Description:

The primary objectives of this study are to assess response (as measured by increase in blood counts, cytogenetic/molecular changes in the bone marrow, improved endurance) to the supplements treatment.

The secondary objectives are to determine:

Quality of life assessment(FACT: QOL Questionnaire) Cancer fatigue reduction. Physiological functioning assessment Rate and depth transfusion reduction Duration of response. Time to progression. Overall survival. Estimated cytokine profile and another immunological and biochemical parameters of mitochondrial function before and after six months of treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

Patient willing and able complies with the protocol requirements. Patient given voluntary written informed consent before performance of any study-related procedure that is not part of standard medical care; with the understanding that the consent may be withdrawn by the patient at any time without prejudice to their future medical care.

Patient is older than 18 years at the time of signing the informed consent. Patients older than 80 years will sign informed consent after psycho-geriatric evaluation.

Patient diagnosed with Myelodysplastic syndrome, Low risk and intermediate-1risk according to international prognostic scoring system with hemoglobin level less than 11g/l or platelets less than 100000/ mcl or absolute neutrophils count less than 1000/mcl. With or without fatigue syndrome.

INT-2 and high risk patients may be included into this trial when they are not eligible for other treatment except Best Supportive Cure or failure to other conventional treatment approach.

Bone marrow aspiration examination including cytogenetics performed up to 12 months before inclusion and absence clinic-laboratory evidence of progressive disease in last month Patient has a life-expectancy > 3 months

Exclusion Criteria:

Any serious medical conditions, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.

Pregnant or lactating females. Prior history of malignancies, other than MDS, unless the subject has been free of the disease for = 3 years. Exceptions include the following: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological finding of prostate cancer (TNM stage of T1a or T1b).

Bone marrow blast count >30%. Patient has known active infectious hepatitis B or C, or HIV infection Administration of investigational drugs in the last 3 months. High risk MDS patients and INT-2 patients who are candidates for cytoreductive or epigenetics treatment.

Any psychological, sociological condutions likely to affect compliance with the study follow-up schedule.

Study Design

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

Dietary Supplement:
• Coenzyme Q10U, L-carnitine

Locations

Country	Name	City	State
Israel	Kaplan Medical Center	Rehovot

Sponsors (2)

Lead Sponsor	Collaborator
Kaplan Medical Center	Weizmann Institute of Science

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Hemoglobin, Platlets,White blood counts		12 weeks,24 weeks	Yes
Secondary	Overall response rate		24 weeks	No
Secondary	Progression free survival		24 weeks,52 weeks	No
Secondary	Duration of response		24 weeks 52 weeks	No
Secondary	Quality of life.		12 weeks 24 weeks 36weeks	No