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

Primary Purpose

Myelodysplastic Syndrome

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Coenzyme Q10U, L-carnitine
Sponsored by
Kaplan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Ultra coenzyme Q10, L-carnitine

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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any study-related procedure that is not part of standard medical care; with the understanding that the consent may be withdrawn by the patient at any time without prejudice to their future medical care.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

Arm Type

Experimental

Arm Label

Coenzyme Q10U, L-carnitine

Arm Description

Patients receive combination of coenzyme Q10U 180 milligram and L-carnitine 2000 milligram

Outcomes

Primary Outcome Measures

Change from baseline Hemoglobin, Platlets,White blood counts

Secondary Outcome Measures

Overall response rate
Progression free survival
Duration of response
Quality of life.

Full Information

First Posted
January 15, 2014
Last Updated
January 19, 2014
Sponsor
Kaplan Medical Center
Collaborators
Weizmann Institute of Science
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1. Study Identification

Unique Protocol Identification Number
NCT02042482
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaplan Medical Center
Collaborators
Weizmann Institute of Science

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
Ultra coenzyme Q10, L-carnitine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coenzyme Q10U, L-carnitine
Arm Type
Experimental
Arm Description
Patients receive combination of coenzyme Q10U 180 milligram and L-carnitine 2000 milligram
Intervention Type
Dietary Supplement
Intervention Name(s)
Coenzyme Q10U, L-carnitine
Primary Outcome Measure Information:
Title
Change from baseline Hemoglobin, Platlets,White blood counts
Time Frame
12 weeks,24 weeks
Secondary Outcome Measure Information:
Title
Overall response rate
Time Frame
24 weeks
Title
Progression free survival
Time Frame
24 weeks,52 weeks
Title
Duration of response
Time Frame
24 weeks 52 weeks
Title
Quality of life.
Time Frame
12 weeks 24 weeks 36weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kalman Filanovsky,, MD
Phone
972-89441747
Email
kalmanph@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Lev Shvidel, MD
Phone
97289441383
Email
levsh@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalman Kalman, MD
Organizational Affiliation
Kaplan Medical Center, Institute of hematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kalman Filanovsky, MD
Phone
97289441747
Email
kalmanph@clalit.org.il

12. IPD Sharing Statement

Learn more about this trial

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

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