Repurposing Riluzole for Cancer-Related Cognitive Impairment: a Pilot Trial

Description

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.

Conditions

Breast Cancer

Study Overview

Study Details

Study overview

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.

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

Repurposing Riluzole for Cancer-Related Cognitive Impairment: a Pilot Trial

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Orange

Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, California, United States, 92868

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Presence of 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Irvine,

Alexandre Chan, PharmD, MPH, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

2026-12