Using Riluzole to Help Breast Cancer Survivors with Cognitive Issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.