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Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial

RecruitingPhase 2

RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* Presence of primary brain tumors or brain metastases.
* Receive a primary chemotherapy regimen that does not include anthracycline- or platinum- containing chemotherapy.
* Unwilling to undergo neuropsychological assessments necessary for the study.
* 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.
* 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 and/or ALT ≥ 3 X upper limit normal (ULN).
* Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.

About the study

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.

What is being tested

Sponsor: University of California, Irvine · Participants: 24 · Started: Dec 23, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07447050

Locations in the U.S.

CaliforniaChao Family Comprehensive Cancer Center, University of California Irvine, Orange

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.