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NCT Number: NCT06580002

Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial

This is a phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining the impact of riluzole therapy on circulating brain derived neuropathic factor (BDNF) levels in cancer survivors (recently completing prior treatment regimens) or patients who have received whole brain radiation for benign or malignant tumors with cancer related cognitive impairment.

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Key information

Conditions

Breast Cancer Adnexal Diseases Blood Protein Disorders Brain Cancer Brain Diseases Brain Neoplasms Breast Diseases Breast Neoplasms Cardiovascular Diseases Central Nervous System Diseases Central Nervous System 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 Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Genitourinary Cancer Gonadal Disorders Gynecologic Cancer Head and Neck Cancer Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Leukemia Leukemia, Lymphoid Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoid Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Male Urogenital Diseases Melanoma Multiple Myeloma Mycosis Fungoides Myeloma Multiple Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplasms, Plasma Cell Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-Hodgkin Lymphoma Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms Paraproteinemias Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urinary Bladder Cancer Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Vascular Diseases

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

Location contact

Alexandre Chan, PharmD, MPH

CONTACT

[email protected]

877-827-8839

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cohort-specific inclusion for male and female patients.

a. Cohort A (no prior cranial radiation) i. Diagnosed with one of the following:

  • Breast cancer exposed to treatment including chemotherapy, radiotherapy, surgery and/or other breast cancer interventions.
  • Non-breast cancer patients exposed to anthracyclines- or platinum-containing chemotherapy within the past 3 years.
  • Non-breast cancer patients exposed to other anticancer therapies within the past 3 years.

b. Cohort B (prior cranial radiation)

  • Previously received radiotherapy or radiosurgery to the brain for benign, malignant, or metastatic tumors.
  • Life expectancy > 6 months
  • Washout from investigational and conventional interventions is up to the discretion of the investigator. Concurrent participation in another intervention is allowable if judged by the Principal Investigator that this would not be scientifically or medically incompatible with this study.
  • ≥18 years of age
  • Perceived by patient or investigator that cognitive function has worsened since receipt of cranial radiation or cancer treatment.
  • Able to provide informed consent.
  • Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires.
  • 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

  • Cohort-specific exclusion for male and female patients:
  • Cohort A (no prior cranial radiation)
  • History of or current presence of primary brain tumors or brain metastases.
  • Cohort B (prior cranial radiation)
  • Diagnosed with high grade glioma.
  • Unwilling to undergo neuropsychological assessments necessary for the study.
  • Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Persons of child-bearing potential (POCBP) must have a negative pregnancy test at screening if there is suspicion of pregnancy.

a. Female 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 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 or ALT ≥ 3x 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

Other names: RILUTEK

Placebo

Drug

Given PO

Primary outcomes

  1. Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer survivors experiencing cognitive impairment (CRCI)

    Time frame: 8 weeks

    Comparing mean plasma BDNF values at each patient visit point, including before the intervention, at the midpoint, and at the endpoint of the study.

Secondary outcomes

  1. Cognitive Function Scores (FACT-Cog)

    Time frame: 8 weeks

    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: 8 weeks

    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]

1-877-827-8839

University of California Irvine Medical

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Repurposing Riluzole for Augmenting Brain-Derived Neuropathic Factor (BDNF) Levels and Cognitive Function in Patients Experiencing Cancer-Related Cognitive Impairment: An Interventional Pilot Clinical Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 30, 2024
Registry last updated
Jul 14, 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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