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REFOCUS: Riluzole for Preventing Cognitive Dysfunction in Cancer Patients Receiving Chemotherapy

This study is testing if a drug called Riluzole can help prevent thinking and memory problems (cognitive dysfunction) in people with certain cancers who are receiving chemotherapy. You might be able to join if you are 18 or older, have breast, sarcoma, stomach, lung, or head and neck cancer, and are scheduled to receive specific types of chemotherapy. The study will compare Riluzole to a placebo (an inactive pill) to see if Riluzole changes levels of a brain protein called Brain-Derived Neurotrophic Factor (BDNF) over 6 months. The current recruitment status is unclear.

Study design
This is a Phase 2a, randomized, double-blinded, placebo-controlled pilot study. It plans to enroll 24 participants.
What's involved
You would take either Riluzole or a placebo by mouth. You would also need to complete questionnaires and computerized assessments.
Compensation
Not stated in the trial record.
Follow-up
Changes in BDNF levels will be measured over 6 months.

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NCT07447050

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

Recruiting
PHASE2Ages 18+InterventionalPrevention
University of California, Irvine
~24 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:RiluzolePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer patients receiving chemotherapy
Measured over 6 months

Conditions

Breast Cancer
Sarcoma
Gastric (Stomach) Cancer
Lung Cancer
Head and Neck Cancer
Colorectal Cancer
Ovarian Cancer
Liver Cancer
Genitourinary Cancer
Gynecologic Cancer

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Where it's being run

1 sites across 1 states
California1

Study leadership

  • Alexandre Chan, PharmD, MPH · PRINCIPAL_INVESTIGATOR · Chao Family Comprehensive Cancer Center

Who to contact

Chao Family Comprehensive Cancer Center University of California, Irvine
[email protected]
877-827-8839
Email the study team

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Eligibility criteria

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

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.

What this trial measures

  • Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer patients receiving chemotherapy6 months

    Comparing mean plasma BDNF values at each patient visit point, including before the intervention, at subsequent ongoing safety monitoring visits, and at the endpoint of the study.