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

Phase 2

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Riluzole; Drug: Placebo

• Registration Number: NCT06580002
• Lead Sponsor: University of California, Irvine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-08-28
• Study First Posted: 2024-08-30
• Status Verified: 2024-12
• Study Start: 2024-12-02
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Riluzole	Riluzole	Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for 8 weeks
Placebo	Placebo	Study participants randomized to this arm will take a placebo, that matches the appearance of 50 mg capsule of riluzole, twice daily (every 12 hours) for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in breast cancer survivors experiencing cognitive impairment (CRCI)	8 weeks	Comparing mean plasma BDNF values at each patient visit point, including before the intervention, at the midpoint, and at the endpoint of the study.

Secondary Outcome Measures

Name	Time	Method
Cognitive Function Scores (FACT-Cog)	8 weeks	Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) scores, including both cumulative and perceived cognitive impairment scores. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes.There are four other scoring subscales in FACT-Cog v3: perceived cognitive impairments (PCI; 18 items); perceived cognitive abilities (7 items); impact of perceived cognitive impairment on QOL (4 items); and comments from others on cognitive function (4 items). Both total and PCI scores will be calculated in this study. Total score is calculated by summing scores from all the items and ranges from 0-148, and higher scores represent better subjective cognitive functioning. Similarly, PCI score is calculated by summing responses of all relevant items and ranges from 0 to 72.
Cognitive Function Scores (CANTAB)	8 weeks	The study will assess the effects of riluzole on cognitive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB) scores across five cognitive domains. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes. Cognitive domains of response speed, learning and memory, working memory, multitasking, and sustained attention will be assessed with CANTAB®. Using International Cognition and Cancer Task Force (ICCTF criteria), overall cognitive impairment is defined as ≥ 2 standard deviations below normative mean on at least 1 cognitive test or ≥ 1.5 standard deviations below normative mean on 2 or more tests.

Trial Locations

Locations (1)

Chao Family Comprehensive Cancer Center, University of California Irvine; 🇺🇸 Orange, California, United States