Repurposing Riluzole for Augmenting Brain-Derived Neuropathic Factor (BDNF) Levels and Cognitive Function in Patients Experiencing Cancer-Related Cognitive Impairment: An Interventional Pilot Clinical Trial
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 in cancer survivors (recently completing prior treatment regimens) or patients who have received whole brain radiation for benign or malignant tumors with cancer related cognitive impairment.
• Cohort-specific inclusion for male and female patients.
• a. Cohort A (no prior cranial radiation) i. Diagnosed with one of the following:
⁃ 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.
‣ b. Cohort B (prior cranial radiation)
⁃ Previously received radiotherapy or radiosurgery to the brain for benign, malignant, or metastatic tumors.
⁃ Life expectancy \> 6 months
• Washout from investigational and conventional 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.
• ≥18 years of age
• Perceived by patient or investigator that cognitive function has worsened since receipt of cranial radiation or 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 participate if they cannot complete computerized assessments, as long as they can still complete the questionnaires with assistance.