None listed
Conditions
Brief summary
This study seeks to detect chemotherapy-associated neurocognitive impairment in patients with Acute Myeloid Leukemia, using Neurocogntive Assessment and Magnetic Resonance Imaging. Who is it for? You may be eligible to join this study if you are aged 18 and above and are commencing induction chemotherapy for Acute Myeloid Leukaemia (AML). Study details This prospective longitudinal pilot study seeks to determine the prevalence and severity of chemotherapy-associated neurocognitive impairment (CANI) in patients undergoing treatment for AML, and to evaluate the feasibility of using magnetic resonance imaging as a biomarker of CANI in this population. Each participant will undergo Neurocognitive Assessment (NCA) and Magnetic Resonance Imaging Quantitative Susceptibility Mapping of brain iron (MRI-QSM) before and after their treatment for AML It is hoped that the findings from this trial will provide information regarding the incidence of chemotherapy associated neurocognitive impairment during AML treatment, and the feasibility of using MRI-QSM as a diagnostic tool in these patients.
Interventions
Prospective observational longitudinal cohort study (pilot study).
Patients undergoing standard chemotherapy treatment will be eligible for participation in this study.
In addition to their standard management, participants will undergo observations at three time points to identify any potential signs of chemotherapy-associated neurocognitive impairment (CANI).
These observations include:
- Neurocognitive Assessment (NCA), in the form of a one-hour standardised interview with a clinical neurops
Prospective observational longitudinal cohort study (pilot study). Patients undergoing standard chemotherapy treatment will be eligible for participation in this study. In addition to their standard management, participants will undergo observations at three time points to identify any potential signs of chemotherapy-associated neurocognitive impairment (CANI). These observations include: - Neurocognitive Assessment (NCA), in the form of a one-hour standardised interview with a clinical neuropsychologist (see below); and - Magnetic resonance imaging with quantitative susceptibility mapping (MRI-QSM) brain imaging. The observations will be performed at baseline, at completion of chemotherapy, and then again at 6 months following completion of all therapy. The 1-hour standardised NCA will contain the following validated assessment tools: 1) Test of Premorbid Function (TOPF), which will provide an overall estimate of the participant’s overall intelligence level. Number of years of education will be documented. 2) Mini Mental State Examination (MMSE) will provide an indication of global cognitive functioning. 3) Cognition will be assessed using measures to evaluate motor speed (the Finger Tapping Test), auditory attention and working memory (Wechsler Memory Scale – Third Edition Digit Span), verbal learning and memory (Rey Auditory Verbal Learning Test) and aspects of executive functioning including mental flexibility (Trail Making Test) and verbal generativity (Controlled Oral Word Association Test (COWAT). 4) Psychological variables will be evaluated through self-report questionnaires canvasing anxiety and depression (Hospital Anxiety and Depression Scale), patient perception of quality of life – European Organisation for Research and Treatment of Cancer Quality of Life Scale (EORTC-QLQ-C30) and evaluation of subjective symptoms of fatigue (EORTC-QLQ-FA12). An overall composite score will be tallied for the NCA at each Time Point.
Sponsors
Metro North Hospital and Health Service
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults commencing induction chemotherapy for Acute Myeloid Leukaemia (AML).
Exclusion criteria
Medical contraindications to MRI according to institutional policy;
Outcome results
None listed