RecruitingPhase 2NCT06580002
Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial
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
Sponsor
University of California, Irvine
Enrollment
51 participants
Start Date
Dec 2, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria11
- Female and male patients 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
- 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.
- ≥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 participate if they cannot complete computerized assessments, as long as they can still complete the questionnaires with assistance.
Exclusion Criteria8
- 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.
- a. 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.
Interventions
DRUGRiluzole
Given PO
DRUGPlacebo
Given PO
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06580002
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