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Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT07447050•University of California, Irvine

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, United States

Key Dates

Start Date

December 23, 2025

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2028

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

Breast CancerSarcomaGastric (Stomach) CancerLung CancerHead and Neck CancerColorectal CancerOvarian CancerLiver CancerGenitourinary CancerGynecologic Cancer

Interventions

Riluzole

DRUG

Placebo

OTHER

Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

877-827-8839 ucstudy@uci.edu

University of California Irvine Medical

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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