Riluzole to Prevent Thinking and Memory Problems in People Receiving Chemotherapy for Cancer
Tests riluzole against placebo for protecting thinking in adults having chemotherapy for cancer.
Plain-language title generated from the registry record
Registry title: Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial
Key facts
- Where
- Orange, United StatesSee the site
- Phase
- Phase 2
Where in United States
- Chao Family Comprehensive Cancer Center, University of California, IrvineOrange, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of California, Irvine
- Trial code
- NCT07447050
- Record updated
- 3 March 2026
- Original description
This is a phase II single-arm, Phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining efficacy of riluzole in preventing cognitive dysfunction in subjects with cancer, who are receiving chemotherapy.Read full original descriptionShow less
RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)
This is a phase II single-arm, Phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining efficacy of riluzole in preventing cognitive dysfunction in subjects with cancer, who are receiving chemotherapy.
Inclusion: Female and male patients diagnosed with cancer and planned to receive an anthracycline- or platinum- containing chemotherapy regimen; ≥18 years of age; Life expectancy > 6 months; Able to provide informed consent; 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: Receive a primary chemotherapy regimen that does not include anthracycline- or platinum- containing chemotherapy; 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; Patients who are breastfeeding, pregnant or are planning to get pregnant during the study period. POCBP must have a negative pregnancy test at screening if there is suspicion of pregnancy. 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 or suspected hypersensitivity to riluzole or to any of its excipients; Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study; Hepatic impairment as indicated by: AST and/or ALT ≥ 3 X upper limit normal (ULN); Presence of primary brain tumors or brain metastases; Unwilling to undergo neuropsychological assessments necessary for the study.