Riluzole to prevent thinking and memory problems during chemotherapy
RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)
This pilot trial tests whether riluzole can prevent thinking and memory problems in adults with cancer receiving anthracycline- or platinum-based chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Drugs / interventions | capmatinib, lapatinib, chemotherapy, methotrexate |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT07447050 on ClinicalTrials.gov |
What this trial studies
This Phase 2a randomized, double-blind, placebo-controlled pilot gives adults receiving anthracycline- or platinum-containing chemotherapy either riluzole or placebo to see if riluzole reduces cognitive decline. Participants complete questionnaires and computerized neuropsychological assessments before, during, and after chemotherapy to measure changes in attention, memory, and executive function. Patients with primary brain tumors or brain metastases are excluded, and participants must have a life expectancy over six months and be able to provide informed consent. The single-site trial is conducted at the Chao Family Comprehensive Cancer Center at the University of California, Irvine.
Who should consider this trial
Good fit: Adults (≥18) with breast, sarcoma, gastric, lung, or head and neck cancers who are scheduled to receive anthracycline- or platinum-containing chemotherapy and can provide informed consent and complete cognitive testing are ideal candidates.
Not a fit: Patients with primary brain tumors or brain metastases, those receiving non‑anthracycline/non‑platinum chemotherapy, and pregnant or breastfeeding individuals are not eligible and thus would not benefit from participation.
Why it matters
Potential benefit: If successful, riluzole could help preserve memory, attention, and overall thinking ability for patients receiving chemotherapy.
How similar studies have performed: Riluzole has shown neuroprotective effects in other neurological conditions and preclinical models, but there are few large randomized trials specifically testing it for chemotherapy-related cognitive decline, so this application is relatively novel clinically.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Orange, California
- Chao Family Comprehensive Cancer Center, University of California Irvine — Orange, California, United States (Recruiting)
Study contacts
- Principal investigator: Alexandre Chan, PharmD, MPH — Chao Family Comprehensive Cancer Center
- Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
- Email: ucstudy@uci.edu
- Phone: 877-827-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.