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

Study 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.

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Key things to know

Main goalPrevention

This describes the study’s primary purpose.

What is being studiedRiluzole and Placebo

The study team can explain what participation involves.

Who it may be forBreast Cancer · Sarcoma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 3, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of California, Irvine

Study sponsor

Study overview

What this study is about

Purpose: Prevention
Study type: Interventional
Phase: Phase 2
Sponsor: University of California, Irvine
Interventions being studied: Drug: Riluzole; Other: Placebo

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Chao Family Comprehensive Cancer Center, University of California IrvineOrange, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 3, 2026. Always confirm current availability with the study team.

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