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

UCI Specialty Areas: Orthopaedics, Cancer
Principal Investigator: Alexandre Chan
A Study On:
Anus
Bones and Joints
Brain and Nervous System
Breast
Cervix
Colon
Corpus Uteri
Esophagus
Eye and Orbit
Hodgkin's Lymphoma
Ill-Defined Sites
Kaposis sarcoma
Kidney
Larynx
Leukemia other
Lip Oral Cavity and Pharynx
Liver
Lung
Lymphoid Leukemia
Melanoma skin
Multiple Myeloma
Mycosis Fungoides
Myeloid and Monocytic Leukemia
Non-Hodgkin's Lymphoma
Other Digestive Organ
Other Endocrine System
Other Female Genital
Other Hematopoietic
Other Male Genital
Other Respiratory and Intrathoracic Organs
Other Skin
Other Urinary

Study Description

The purpose of this research study is to investigate whether riluzole therapy can help prevent cancer-related cognitive impairment (“chemobrain”) in people receiving anthracycline or platinum-based chemotherapy. We will look at how riluzole affects levels of 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 impariment in cancer survivors.

We will also examine whether riluzole affects participants’ perceived cognitive function (based on survey responses) and measured cognitive ability (using established computer-based tests).

Riluzole is already approved by the U.S. Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS) at a dose of 50 mg twice daily. However, its ability to prevent changes in BDNF levels and cognitive function during chemotherapy has not been studied in people with cancer. This research will help us learn if riluzole could be a safe and effective way to protect brain function during chemotherapy.

Eligibility

• Diagnosed with cancer and planned to receive an anthracycline- or platinum- containing chemotherapy regimen

• ≥18 years of age

• Able to provide informed consent

• Must agree to complete and able to complete the questionnaires and computerized assessments

• Presence of brain metastases

• Unwilling to undergo neuropsychological assessments necessary for the study

• Breastfeeding, pregnant or are planning get pregnant during the study period

• History of or suspected hypersensitivity to riluzole or to any of its inactive ingredients

• Patients taking or planning to take medications/substances with potential drug-drug interactions

• Hepatic impairment: Patients with measured serum transaminases 3 times greater than upper limit of normal

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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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