Using Riluzole to Help Breast Cancer Survivors with Cognitive Issues
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 study is testing if the medication riluzole can help breast cancer survivors who are having trouble with thinking and memory feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Irvine Academic / other |
| Drugs / interventions | capmatinib, lapatinib, chemotherapy, methotrexate |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT06580002 on ClinicalTrials.gov |
What this trial studies
This pilot trial is a phase 2a, randomized, double-blinded, placebo-controlled study that investigates the effects of riluzole on brain derived neurotrophic factor (BDNF) levels in breast cancer survivors experiencing cognitive impairment. Participants will receive either riluzole or a placebo to assess changes in cognitive function and BDNF levels. The study aims to determine if riluzole can improve cognitive symptoms related to cancer treatment. Eligible participants include both male and female breast cancer survivors who have perceived cognitive decline since their diagnosis or treatment.
Who should consider this trial
Good fit: Ideal candidates are breast cancer survivors aged 18 and older who have experienced cognitive decline since their diagnosis or treatment.
Not a fit: Patients who have not experienced cognitive impairment related to their cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option to alleviate cognitive impairment in breast cancer survivors.
How similar studies have performed: While this approach is novel in the context of cancer-related cognitive impairment, similar studies have explored the effects of other interventions on cognitive function in cancer survivors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female and male patients diagnosed with one of the following: 1. Breast cancer exposed to treatment including chemotherapy, radiotherapy, surgery and/or other breast cancer interventions 2. Non-breast cancer patients exposed to anthracyclines- or platinum-containing chemotherapy within the past 3 years 3. Non-breast cancer patients exposed to other anticancer therapies within the past 3 years * Washout from investigational 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 cancer diagnosis and/or beginning of 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. Exclusion Criteria: * Presence of brain metastasis * Unwilling to undergo neuropsychological assessments necessary for the study. * Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Women of child-bearing potential (WOCBP) 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. * 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.
Where this trial is running
Orange, California
- Chao Family Comprehensive Cancer Center, University of California Irvine — Orange, California, United States (Recruiting)
Study contacts
- Principal investigator: Alexandre Chan, PharmD, MPH — Chao Family Comprehensive Cancer Center
- Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
- Email: ucstudy@uci.edu
- Phone: 1-877-827-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.