The Effect of Combination Ultra Q10 and L-carnitine on the Course of Myelodysplastic Syndrome
Information source: Kaplan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myelodysplastic Syndrome
Intervention: Coenzyme Q10U, L-carnitine (Dietary Supplement)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Kaplan Medical Center Official(s) and/or principal investigator(s): Kalman Kalman, MD, Principal Investigator, Affiliation: Kaplan Medical Center, Institute of hematology
Overall contact: Kalman Filanovsky, , MD, Phone: 972-89441747, Email: kalmanph@clalit.org.il
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
Clinical Details
Official title: The Effect of the Nutritional Supplements: Ultra Q10 and L-carnitine on the Clinical Course of Myelodysplastic Syndrome
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from baseline Hemoglobin, Platlets,White blood counts
Secondary outcome: Overall response rateProgression free survival Duration of response Quality of life.
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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part of standard medical care; with the understanding that the consent may be withdrawn by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.
Locations and Contacts
Kalman Filanovsky, , MD, Phone: 972-89441747, Email: kalmanph@clalit.org.il
Kaplan Medical Center, Rehovot 76100, Israel; Recruiting Kalman Filanovsky, MD, Phone: 97289441747, Email: kalmanph@clalit.org.il
Additional Information
Starting date: May 2013
Last updated: January 19, 2014
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