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RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Chao Family Comprehensive Cancer Center, University of California Irvine
RECRUITING
Orange
Contact Information
Primary
Chao Family Comprehensive Cancer Center University of California, Irvine
ucstudy@uci.edu
877-827-8839
Backup
University of California Irvine Medical
Time Frame
Start Date: 2025-12-23
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 24
Treatments
Experimental: Riluzole
Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for up to 6 months
Placebo_comparator: Placebo
Study participants randomized to this arm will take a placebo, that matches the appearance of 50 mg capsule of riluzole, twice daily (every 12 hours) for up to 6 months
Sponsors
Leads: University of California, Irvine

This content was sourced from clinicaltrials.gov

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