Clinical trial NCT06580002: Repurposing Riluzole for Cancer-Related Cognitive Impairment: a Pilot Trial
Official title: Repurposing Riluzole for Augmenting Brain-Derived Neuropathic Factor (BDNF) Levels and Cognitive Function in Breast Cancer Patients Experiencing Cancer-Related Cognitive Impairment: an Interventional Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 of breast cancer survivors with cancer related cognitive impairment.


Eligibility criteria: Inclusion Criteria:

* Female and male patients diagnosed with breast cancer
* Past exposure to chemotherapy, radiotherapy, surgery and/or other breast cancer interventions. There is no minimum treatment time to be considered eligible.
* Washout of 30 days from investigational interventions is required if the patient was previously treated in a research study. There is no washout required from placebo investigational interventions. Washout for conventional interventions is up to the discretion of the Investigator, if the conventional intervention is not planned to be concurrently administered with riluzole/placebo.
* ≥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 still 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.

Primary outcomes:
measure: Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in breast cancer survivors experiencing cognitive impairment (CRCI)
timeFrame: 8 weeks
Secondary outcomes:
measure: Cognitive Function Scores (FACT-Cog)
timeFrame: 8 weeks
measure: Cognitive Function Scores (CANTAB)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center, University of California Irvine
state: California
Study officials:
affiliation: Chao Family Comprehensive Cancer Center
name: Alexandre Chan, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
References: