NCT06580002 Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial
| NCT ID | NCT06580002 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Irvine |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2024-12-02 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 benign or malignant tumors with cancer related cognitive impairment.
Eligibility Criteria
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.
Contact & Investigator
Chao Family Comprehensive Cancer Center University of California, Irvine
✉ ucstudy@uci.edu📞 1-877-827-8839
Alexandre Chan, PharmD, MPH
PRINCIPAL INVESTIGATOR
Chao Family Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06580002 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06580002 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06580002 currently recruiting?
Yes, NCT06580002 is actively recruiting participants. Contact the research team at ucstudy@uci.edu for enrollment information.
Where is the NCT06580002 trial being conducted?
This trial is being conducted at Orange, United States.
Who is sponsoring the NCT06580002 clinical trial?
NCT06580002 is sponsored by University of California, Irvine. The principal investigator is Alexandre Chan, PharmD, MPH at Chao Family Comprehensive Cancer Center. The trial plans to enroll 75 participants.
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