The Effect of Combination Ultra Q10 and L-carnitine on the Course of Myelodysplastic Syndrome
Myelodysplastic Syndrome
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Ultra coenzyme Q10, L-carnitine
Eligibility Criteria
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any study-related procedure that is not part of standard medical care; with the understanding that the consent may be withdrawn by the patient at any time without prejudice to their future medical care.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.
Sites / Locations
- Kaplan Medical CenterRecruiting
Arms of the Study
Arm 1
Experimental
Coenzyme Q10U, L-carnitine
Patients receive combination of coenzyme Q10U 180 milligram and L-carnitine 2000 milligram