Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial

NCT07447050 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY00000370UCI 25-48
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric (Stomach) Cancer; Lung Cancer; Head and Neck Cancer; Colorectal Cancer; Ovarian Cancer; Liver Cancer; Genitourinary Cancer; Gynecologic Cancer; Breast Cancer; Sarcoma

Outcome Measures

Primary Outcomes (1)

• Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer patients receiving chemotherapy

  Comparing mean plasma BDNF values at each patient visit point, including before the intervention, at subsequent ongoing safety monitoring visits, and at the endpoint of the study.

  6 months

Secondary Outcomes (2)

• Cognitive Function Scores (FACT-Cog)

  6 months

• Cognitive Function Scores (CANTAB)

  6 months

Study Arms (2)

Riluzole

EXPERIMENTAL

Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for up to 6 months

Drug: Riluzole

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Riluzole DRUG

Given PO

Riluzole

Placebo OTHER

Given PO

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 having smoked within the last month), abametapir, cannabis, capmatinib, lapatinib, methotrexate, and levoketoconazole.
• Hepatic impairment as indicated by: AST and/or ALT ≥ 3 X upper limit normal (ULN).
• Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Sarcoma; Stomach Neoplasms; Lung Neoplasms; Head and Neck Neoplasms; Colorectal Neoplasms; Ovarian Neoplasms; Liver Neoplasms; Urogenital Neoplasms

Interventions

Riluzole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Liver Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Alexandre Chan, PharmD, MPH

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

877-827-8839; ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair & Professor of Clinical Pharmacy

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: December 23, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)