Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial (NCT07447050) | Clinical Trial Compass
RecruitingPhase 2
Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial
United States24 participantsStarted 2025-12-23
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer patients receiving chemotherapy
Timeframe: 6 months
Trial details
NCT IDNCT07447050
SponsorUniversity of California, Irvine
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-12-31
Contact for this trial
Chao Family Comprehensive Cancer Center University of California, Irvine