Repurposing Riluzole for Cancer-Related Cognitive Impairment: a Pilot Trial

Open to people ages 18 years and up

• Female and male patients diagnosed with breast cancer
• Past exposure to chemotherapy, radiotherapy, surgery and/or other breast cancer interventions. There is no minimum treatment time to be considered eligible.
• Washout of 30 days from investigational interventions is required if the patient was previously treated in a research study. There is no washout required from placebo investigational interventions. Washout for conventional interventions is up to the discretion of the Investigator, if the conventional intervention is not planned to be concurrently administered with riluzole/placebo.
• ≥18 years of age
• Perceived by patient or investigator that cognitive function has worsened since cancer diagnosis and/or beginning of cancer treatment
• Able to provide informed consent.
• Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires.
• Patients must agree to complete and be able to complete the questionnaires and computerized assessments used to measure functional outcomes.

Note: Patients who have visual impairment or have degenerative conditions (e.g. Parkinsons's disease, etc.) can still participate if they cannot complete computerized assessments, as long as they can still complete the questionnaires with assistance.

• Presence of 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.
  1. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.
• History of suspected hypersensitivity to riluzole or to any of its excipients.
• Patients taking or planned to take medications/substances with potential drug-drug interactions: pixantrone, current smoker (defined as having smoked within the last month), abametapir, cannabis, capmatinib, lapatinib, methotrexate, and levoketoconazole.
• Hepatic impairment as indicated by: AST or ALT ≥ 3x upper limit normal (ULN)
• Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.