Could an ALS drug clear the fog of chemo brain?
NCT ID NCT06580002
First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time
Summary
This study tests whether riluzole, a drug already used for ALS, can help cancer survivors who struggle with memory, focus, and mental clarity after treatment — a condition called cancer-related cognitive impairment. Researchers will measure changes in a brain protein called BDNF and track thinking skills over time. The trial includes people with various cancers who completed treatment recently or had whole-brain radiation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a drug called riluzole, which is typically used for ALS, being repurposed to potentially boost brain function
- What this could lead to
- If it works, this could point toward a new way to treat 'chemo brain' — the mental fog many cancer survivors experience after treatment.
- What could go wrong
- This is a small, early pilot study, so results may not be conclusive. Riluzole can cause side effects like liver issues or drowsiness, and it may not improve thinking at all.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 75 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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 2. 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. 3. ≥18 years of age 4. Perceived by patient or investigator that cognitive function has worsened since receipt of cranial radiation or cancer treatment. 5. Able to provide informed consent. 6. Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires. 7. 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: 1. Cohort-specific exclusion for male and female patients: 1. Cohort A (no prior cranial radiation) * History of or current presence of primary brain tumors or brain metastases. 2. Cohort B (prior cranial radiation) * Diagnosed with high grade glioma. 2. Unwilling to undergo neuropsychological assessments necessary for the study. 3. 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. 4. History of suspected hypersensitivity to riluzole or to any of its excipients. 5. 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. 6. Hepatic impairment as indicated by: AST or ALT ≥ 3x upper limit normal (ULN) 7. Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Chao Family Comprehensive Cancer Center, University of California Irvine
RECRUITINGOrange, California, 92868, United States
Contact Email: •••••@•••••
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