Active, currently enrolling
Impact of Targeted Therapy on Cancer-Related Cognitive Impairment
NCT No.: NCT00000001
Study Type: INTERVENTIONAL
Phase:
n/a
Region: Colorado
Acronym:
Official Title
Impact of Targeted Therapy on Cancer-Related Cognitive Impairment
Purpose
Primary Aim:
Characterize differences in subjective CRCI longitudinally among patients receiving TKIs for CML or CLL.
Secondary Aims:
• Characterize differences in objective CRCI longitudinally among patients receiving TKIs for CML or CLL.
• Identify risk factors for CRCI before and during TKI therapy.
• Identify biobehavioral mechanisms underlying the effect of TKIs on CRCI.
Detailed Description
Cancer-related cognitive impairment (CRCI) is common and distressing among cancer survivors. Tyrosine kinase inhibitors (TKIs) are among the first, most prolific, and most successful classes of targeted therapy. TKIs are also rapidly expanding, with over 40 FDA-approved TKIs for cancer. Studying the impact of TKIs on CRCI will improve awareness of CRCI, identify modifiable mechanisms, and inform development of new interventions.
This study will recruit patients with chronic myelogenous leukemia (CML) or chronic lymphocytic leukemia (CLL) to begin TKI therapy or that have just begun TKI therapy to complete assessments before starting TKIs (Assessment 1) as well as 6 and 12 months later (Assessments 2 and 3). Controls will complete assessments at similar intervals. Each assessment will include a saliva sample, patient-reported outcomes (PROs), a neuropsychological battery, and ecological momentary assessment (EMA) of CRCI for 1 week.
Eligibility Criteria
Inclusion Criteria
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Inclusion Criteria: TKI recipients
• Participants must have a diagnosis of CML or CLL.
• Participants must be scheduled to receive their first dose of TKI therapy for CML or CLL within 30 days or have received their first dose of TKI therapy for CML or CLL within the previous 30 days.
• Participants must be ≥ 18 years of age.
• Participants must be able to speak and read English.
• Participants must be able to understand and willing to sign an informed consent document.
Inclusion Criteria: Cancer-Free Individuals Serving as Controls
• Participants must be ≥ 18 years of age.
• Participants must be able to speak and read English.
• Participants must be able to understand and willing to sign an informed consent document.
• Each participant must be matched to a TKI recipient participant based on sex and age ±5 years (i.e., must be no more than 5 years older or younger than the TKI recipient participant).
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Exclusion Criteria
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• Participants must have no history of metastatic cancer, primary brain tumor, or brain irradiation.
• Participants must have no history of TKI therapy.
• Participants must have no history of cytotoxic chemotherapy, immune checkpoint inhibitor therapy, hormonal therapy, biologic therapy, radiotherapy within the past 5 years. However, permitted treatments include prior use of hydroxyurea for the treatment of CML or CLL as well as treatment with obinutuzumab or rituximab concurrent with TKI therapy for CLL.
• Participants must have no history of stroke within the past year and no remaining cognitive symptoms from any stroke prior to the past year.
• Participants must have no history of head trauma with loss of consciousness within the year prior to consent.
• Participants must have no diagnosis of dementia or severe neurodegenerative disease impairing daily functioning.
• Participants must have no psychiatric condition that led to hospitalization within the past year.
• Participants must not be currently pregnant.
• Participants must not be colorblind based on self-report.
• Participants must not be study staff who have previously viewed or administered the objective cognitive function measures (e.g., CANTAB).
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Keywords and/or Specific Medical Conditions
- Cancer Related Cognitive Impairment (CRCI)
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- Chronic Lymphocytic Leukemia (CLL)
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- Chronic Myelogenous Leukemia (CML)
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- Tyrosine Kinase Inhibitors (TKI)
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Sponsors
- University of Rochester NCORP Research Base (URCC)
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