This is a phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining the impact of riluzole therapy on circulating brain derived neuropathic factor (BDNF) levels of cancer survivors with cancer related cognitive impairment.
Breast cancer exposed to treatment including chemotherapy, radiotherapy, surgery and/or other breast cancer interventions
Non-breast cancer patients exposed to anthracyclines- or platinum-containing chemotherapy within the past 3 years
Non-breast cancer patients exposed to other anticancer therapies within the past 3 years
Washout from investigational interventions is up to the discretion of the Investigator. Concurrent participation in another intervention is allowable if judged by the Principal Investigator that this would not be scientifically or medically incompatible with this study.
Presence of brain metastasis
Unwilling to undergo neuropsychological assessments necessary for the study.
Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening if there is suspicion of pregnancy.
History of suspected hypersensitivity to riluzole or to any of its excipients.
Parallel
Riluzole
DrugGiven PO
Placebo
DrugGiven PO
Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer survivors experiencing cognitive impairment (CRCI)
Comparing mean plasma BDNF values at each patient visit point, including before the intervention, at the midpoint, and at the endpoint of the study.
Cognitive Function Scores (FACT-Cog)
Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) scores, including both cumulative and perceived cognitive impairment scores. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes.There are four other scoring subscales in FACT-Cog v3: perceived cognitive impairments (PCI; 18 items); perceived cognitive abilities (7 items); impact of perceived cognitive impairment on QOL (4 items); and comments from others on cognitive function (4 items). Both total and PCI scores will be calculated in this study. Total score is calculated by summing scores from all the items and ranges from 0-148, and higher scores represent better subjective cognitive functioning. Similarly, PCI score is calculated by summing responses of all relevant items and ranges from 0 to 72.
Cognitive Function Scores (CANTAB)
The study will assess the effects of riluzole on cognitive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB) scores across five cognitive domains. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes. Cognitive domains of response speed, learning and memory, working memory, multitasking, and sustained attention will be assessed with CANTAB®. Using International Cognition and Cancer Task Force (ICCTF criteria), overall cognitive impairment is defined as ≥ 2 standard deviations below normative mean on at least 1 cognitive test or ≥ 1.5 standard deviations below normative mean on 2 or more tests.
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