Breast CancerPhase 2NCT06580002
Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial
A Phase 2 study testing Riluzole in people with Breast Cancer and Sarcoma, run by University of California, Irvine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Sarcoma, Gastric Cancer
- What is being tested?
- Riluzole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2024to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort-specific inclusion for male and female patients.
- 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.
- Cohort B (prior cranial radiation)
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center, University of California Irvine
Orange, California, 92868
Alexandre Chan, PharmD, MPH, 877-827-8839, ucstudy@uci.edu
About this study
Official 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
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.
- Conditions
- Breast Cancer, Sarcoma, Gastric Cancer, Lung Cancer, Head and Neck Cancer, Colorectal Cancer
- Being tested
- Riluzole, Placebo
- Medical subject headings
- Breast Neoplasms, Sarcoma, Stomach Neoplasms, Lung Neoplasms, Head and Neck Neoplasms, Colorectal Neoplasms, Ovarian Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiluzoleDrug
Also called RILUTEK
Given PO
PlaceboDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Riluzole | Experimental | Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for 8 weeks Receives: Drug: Riluzole |
| Placebo | Placebo comparator | Study participants randomized to this arm will take a placebo, that matches the appearance of 50 mg capsule of riluzole, twice daily (every 12 hours) for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer survivors experiencing cognitive impairment (CRCI)
Comparing mean plasma BDNF values at each patient visit point, including before the intervention, at the midpoint, and at the endpoint of the study.
Measured: 8 weeks
Secondary outcomes (2)
Cognitive Function Scores (FACT-Cog)
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.
Measured: 8 weeks
Cognitive Function Scores (CANTAB)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start2 Dec 2024
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Chan, University of California, Irvine
- Investigators
- Alexandre Chan, PharmD, MPH, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580002
- Sponsor's protocol ID
- 4994
- Other IDs
- UCI 24-05
- Status last verified
- Jul 2026
- First submitted
- 28 Aug 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06580002
- Acronym / sponsor ID
- 4994
- Conditions
- Breast Cancer, Sarcoma, Gastric Cancer, Lung Cancer, Head and Neck Cancer, Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Riluzole | Experimental | Drug: RiluzoleStudy participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for 8 weeks |
| Placebo | Placebo comparator | Drug: PlaceboStudy participants randomized to this arm will take a placebo, that matches the appearance of 50 mg capsule of riluzole, twice daily (every 12 hours) for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Cohort-specific inclusion for male and female patients.
- 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.
Key exclusion criteria (12 listed)
- Cohort-specific exclusion for male and female patients:
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiluzoleAlso: RILUTEKGiven PO | Drug | Riluzole |
| PlaceboGiven PO | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Cognitive Function Scores (FACT-Cog)
Time frame: 8 weeks
Cognitive Function Scores (CANTAB)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Alexandre Chan, PharmD, MPH principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Riluzole in people with Breast Cancer and Sarcoma, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer survivors experiencing cognitive impairment (CRCI) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.