NCT07447050RecruitingPhase 2
Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial
RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 25 Feb 2026
- Start date
- 23 Dec 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of California, Irvine
- Diseases
- Head and neck cancer, Lung cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer, Sarcoma
- NCT number
- NCT07447050
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 24
- From 23 Dec 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receive a primary chemotherapy regimen that does not include anthracycline- or platinum- containing chemotherapy.
- 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.
Other illness
- 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.
- Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.
Lab values
- Hepatic impairment as indicated by: AST and/or ALT ≥ 3 X upper limit normal (ULN).
Other
- Presence of primary brain tumors or brain metastases.
- Unwilling to undergo neuropsychological assessments necessary for the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chao Family Comprehensive Cancer Center, University of California, Irvine Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.