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NCT Number: NCT07447050

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

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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric (Stomach) Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Genitourinary Cancer Gonadal Disorders Gynecologic Cancer Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, 92868, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Riluzole

Drug

Given PO

Placebo

Other

Given PO

Primary outcomes

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

    Time frame: 6 months

    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.

Secondary outcomes

  1. Cognitive Function Scores (FACT-Cog)

    Time frame: 6 months

    Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) scores, including both cumulative and perceived cognitive impairment scores. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes.There are four other scoring subscales in FACT-Cog v3: perceived cognitive impairments (PCI; 18 items); perceived cognitive abilities (7 items); impact of perceived cognitive impairment on QOL (4 items); and comments from others on cognitive function (4 items). Both total and PCI scores will be calculated in this study. Total score is calculated by summing scores from all the items and ranges from 0-148, and higher scores represent better subjective cognitive functioning. Similarly, PCI score is calculated by summing responses of all relevant items and ranges from 0 to 72.

  2. Cognitive Function Scores (CANTAB)

    Time frame: 6 months

    The study will assess the effects of riluzole on cognitive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB) scores across five cognitive domains. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes. Cognitive domains of response speed, learning and memory, working memory, multitasking, and sustained attention will be assessed with CANTAB®. Using International Cognition and Cancer Task Force (ICCTF criteria), overall cognitive impairment is defined as ≥ 2 standard deviations below normative mean on at least 1 cognitive test or ≥ 1.5 standard deviations below normative mean on 2 or more tests.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

[email protected]

877-827-8839

University of California Irvine Medical

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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