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

NCT02042482 | Unknown Phase 2

• 1 other identifier: KMC01-35-12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Myelodysplastic Syndrome

Keywords

Ultra coenzyme Q10; L-carnitine

Outcome Measures

Primary Outcomes (1)

• Change from baseline Hemoglobin, Platlets,White blood counts

  12 weeks,24 weeks

Secondary Outcomes (4)

• Overall response rate

  24 weeks

• Progression free survival

  24 weeks,52 weeks

• Duration of response

  24 weeks 52 weeks

• Quality of life.

  12 weeks 24 weeks 36weeks

Study Arms (1)

Coenzyme Q10U, L-carnitine

EXPERIMENTAL

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

Dietary Supplement: Coenzyme Q10U, L-carnitine

Interventions

Coenzyme Q10U, L-carnitine DIETARY_SUPPLEMENT

Coenzyme Q10U, L-carnitine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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any study-related procedure that is not part of standard medical care; with the understanding that the consent may be withdrawn by the patient at any time without prejudice to their future medical care.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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaplan Medical Center: lead
• Weizmann Institute of Science: collaborator

Study Sites (1)

Kaplan Medical Center

Rehovot, 76100, Israel

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Kalman Kalman, MD

  Kaplan Medical Center, Institute of hematology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kalman Filanovsky,, MD

CONTACT

972-89441747; kalmanph@clalit.org.il

Lev Shvidel, MD

CONTACT

97289441383; levsh@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 22, 2014
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

IL (1)