Clinical trial NCT02042482: The Effect of Combination Ultra Q10 and L-carnitine on the Course of Myelodysplastic Syndrome
Official title: The Effect of the Nutritional Supplements: Ultra Q10 and L-carnitine on the Clinical Course of Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Myelodysplastic Syndrome
Keywords: Ultra coenzyme Q10
L-carnitine
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
Collaborators: name: Weizmann Institute of Science
First posted: 2014-01-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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 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any study-related procedure that is not part of standard medical care; with the understanding that the consent may be withdrawn by the patient at any time without prejudice to their future medical care.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.

Primary outcomes:
measure: Change from baseline Hemoglobin, Platlets,White blood counts
timeFrame: 12 weeks,24 weeks
Secondary outcomes:
measure: Overall response rate
timeFrame: 24 weeks
measure: Progression free survival
timeFrame: 24 weeks,52 weeks
measure: Duration of response
timeFrame: 24 weeks 52 weeks
measure: Quality of life.
timeFrame: 12 weeks 24 weeks 36weeks
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Kaplan Medical Center
Study officials:
affiliation: Kaplan Medical Center, Institute of hematology
name: Kalman Kalman, MD
role: PRINCIPAL_INVESTIGATOR
References: