Actively Recruiting
Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial
Led by University of California, Irvine · Updated on 2026-03-03
24
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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.
- Age 18 years or older.
- Life expectancy greater than 6 months.
- Able to provide informed consent.
- Agree and be able to complete questionnaires and computerized assessments; patients with visual impairment or degenerative conditions may participate if they can complete questionnaires with assistance.
You will not qualify if you...
- Presence of primary brain tumors or brain metastases.
- Receiving chemotherapy regimens without 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 postmenopause, tubal ligation, or hysterectomy required if not of childbearing potential.
- History or suspicion of hypersensitivity to riluzole or its excipients.
- Taking or planning to take medications with potential interactions including pixantrone, abametapir, cannabis, capmatinib, lapatinib, methotrexate, levoketoconazole, or current smoker within last month.
- Hepatic impairment with AST and/or ALT ≥ 3 times upper limit normal.
- Serious pre-existing medical conditions that would prevent participation as judged by the investigator.
AI-Screening
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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
CONTACT
U
University of California Irvine Medical
CONTACT
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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