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Cognitive Function and Patient-Reported Quality of Life Outcomes Investigation in Patients Taking Vorinostat

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ClinicalTrials.gov Identifier: NCT02409134
Recruitment Status : Completed
First Posted : April 6, 2015
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Sung Choi, M.D., University of Michigan Rogel Cancer Center

Brief Summary:
Psychological well-being and cognitive function will be measured in patients enrolled on the primary study, NCT01790568, a phase 2 trial of vorinostat plus tacrolimus and methotrexate to prevent graft versus host disease following unrelated donor hematopoietic stem cell transplantation. Validated questionnaires will be administered to assess patients' level of depression, anxiety, quality of life, perceived cognitive functioning, and sleep quality. Cognitive testing will include reliable and valid measures of processing speed, attention, executive function, episodic memory, and visual learning and memory. The purpose of this study is to determine whether these measures are feasible to administer in patients before and at early time points after bone marrow transplantation .

Condition or disease
Quality of Life Graft-vs-Host Disease

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cognitive Function and Patient-Reported Psychological and Functional/Quality of Life Outcomes Investigation in Patients Taking Vorinostat for Graft-versus-Host Disease Prophylaxis
Study Start Date : April 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Vorinostat




Primary Outcome Measures :
  1. Feasibility, as measured by completion of cognitive testing and validated questionnaires at all time points by 50% of newly-accrued patients. [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled on the primary study NCT01790568. Eligible patients who choose not to participate in this add-on study will not be excluded from participating in NCT01790568.
Criteria

Inclusion Criteria:

  • Patients must be enrolled on the parent study (NCT01790568; A phase 2 clinical trial of vorinostat plus tacrolimus and methotrexate to prevent graft versus host disease following unrelated donor hematopoietic stem cell transplantation)
  • Must speak, read and understand English

Exclusion Criteria:

  • Documented evidence of cognitive impairment prior to enrollment on this study (diagnosis of dementia, mild cognitive impairment, or other neurological illnesses that impact cognition).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409134


Locations
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United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Sung Choi, M.D.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sung Choi, M.D., Assistant Professor, University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT02409134     History of Changes
Other Study ID Numbers: UMCC 2015.020
HUM00096406 ( Other Identifier: University of Michigan Cancer Center )
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Keywords provided by Sung Choi, M.D., University of Michigan Rogel Cancer Center:
Bone Marrow Transplantation
Hematologic Malignancies
Adults
Cognition
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Vorinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action