Actively Recruiting
Riluzole for Preventing Cognitive Dysfunction in Cancer Patients Receiving Chemotherapy (REFOCUS) Pilot Trial
Led by University of California, Irvine · Updated on 2026-03-03
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating riluzole to see if it can help prevent cognitive problems in people with cancer who are receiving chemotherapy. This study is a phase II, randomized, double-blinded, placebo-controlled pilot trial focused on patients undergoing anthracycline- or platinum-based chemotherapy. The trial aims to understand how riluzole affects brain function during cancer treatment. Participants are randomly assigned to one of two groups: one group takes 50 mg of riluzole twice daily for up to six months, while the other group receives a placebo that looks like riluzole, taken with the same schedule. Both treatments are given by mouth. The study monitors patients over a six-month period to compare effects between the riluzole and placebo groups. During the trial, participants will complete questionnaires and computerized tests to assess cognitive function, even if they have visual impairments or certain neurological conditions. Researchers will also measure changes in brain-derived neurotrophic factor (BDNF) levels, which relate to brain health. Safety and overall health will be monitored, and the study lasts for six months from the start of treatment.
CONDITIONS
Brief Title
Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with cancer and planned to receive anthracycline- or platinum-containing chemotherapy
- 18 years of age or older
- Life expectancy greater than 6 months
- Able to provide informed consent
- Agree and able to complete questionnaires and computerized cognitive assessments, with assistance if needed for visual impairments or degenerative conditions
You will not qualify if you...
- Presence of primary brain tumors or brain metastases
- Receiving chemotherapy that does not include anthracycline or platinum
- Unwilling to undergo neuropsychological assessments
- Pregnant, breastfeeding, or planning pregnancy during the study; negative pregnancy test required if pregnancy suspected
- History of hypersensitivity to riluzole or its ingredients
- Taking or planning to take medications or substances with potential interactions, including pixantrone, abametapir, cannabis, capmatinib, lapatinib, methotrexate, levoketoconazole, or current smokers
- Hepatic impairment with AST or ALT levels three times or more above normal
- Serious pre-existing medical conditions that would prevent participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants take riluzole or placebo twice daily for up to 6 months while receiving chemotherapy.
Regular visits during chemotherapy as per protocol
Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center, University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
U
University of California Irvine Medical
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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