Riluzole for the Prevention Cognitive Dysfunction in Cancer Patients Receiving Chemotherapy, REFOCUS Trial

Status: active

This phase IIa trial tests the effect of riluzole on memory and thinking (cognitive) in treating cancer patients receiving anthracycline or platinum-based chemotherapy. While chemotherapy is highly effective, it is also associated with cognitive-related impairments often referred to as chemobrain. Symptoms of cognitive impairments, including memory loss, inability to concentrate, and difficulty thinking and functioning, can have a significant negative impact on quality of life. Currently, there is no effective strategy to prevent chemobrain. This study also evaluates how riluzole affects a protein in the blood called brain derived neurotrophic factor (BDNF). BDNF plays an important role in brain health, including memory and thinking, and lower levels have been linked to cognitive impairment in cancer survivors. Riluzole, a type of glutamate release inhibitor, works by changing the activity of certain natural substances in the body that affect nerves and muscles. Riluzole has also been shown to increase circulating BDNF levels. Giving riluzole may be effective in increasing circulating levels of BDNF and prevent declines in cognitive function, including memory and thinking, in cancer patients receiving chemotherapy.

Inclusion Criteria

Female and male patients newly diagnosed with cancer and planned to receive a chemotherapy regimen, with or without targeted therapies/immunotherapy/radiation
≥ 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
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 (PI) that this would not be scientifically or medically incompatible with this study

Exclusion Criteria

Presence of primary brain tumors or brain metastases
Planned to receive a primary anti-cancer regimen that does not include 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. Persons of child-bearing potential (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: * Aspartate aminotransferase (AST) and/or alanine aminotransferase (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

PRIMARY OBJECTIVE:

I. To investigate the impact of riluzole on circulating BDNF levels in cancer patients who are receiving chemotherapy.

SECONDARY OBJECTIVE:

I. To investigate the impact of riluzole on preventing decline of neurocognitive function in patients with cancer who are receiving chemotherapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Starting on the day standard of care chemotherapy begins, patients receive riluzole orally (PO) twice daily (BID). Treatment repeats for up to a maximum of 6 cycles of chemotherapy in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.

ARM II: Starting on the day standard of care chemotherapy begins, patients receive placebo PO BID. Treatment repeats for up to a maximum of 6 cycles of chemotherapy in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 30 days.

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Riluzole for the Prevention Cognitive Dysfunction in Cancer Patients Receiving Chemotherapy, REFOCUS Trial

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Riluzole for the Prevention Cognitive Dysfunction in Cancer Patients Receiving Chemotherapy, REFOCUS Trial

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