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

NCT ID: NCT06580002

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2027-12-31

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 cancer survivors with cancer related cognitive impairment.

Conditions

Breast Cancer; Sarcoma; Gastric Cancer; Lung Cancer; Head and Neck Cancer; Colorectal Cancer; Ovarian Cancer; Liver Cancer; Genitourinary Cancer; Gynecologic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Riluzole

Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for 8 weeks

Group Type: EXPERIMENTAL

Riluzole

Intervention Type: DRUG

Given PO

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Given PO

Interventions

Riluzole

Given PO

Intervention Type: DRUG

Placebo

Given PO

Intervention Type: DRUG

Other Intervention Names

RILUTEK

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Alexandre Chan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandre Chan, PharmD, MPH

Role: PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Locations

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

Role: CONTACT

ucstudy@uci.edu

1-877-827-8839

University of California Irvine Medical

Role: CONTACT

Facility Contacts

Alexandre Chan, PharmD, MPH

Role: primary

ucstudy@uci.edu

877-827-8839

Other Identifiers

UCI 24-05

Identifier Type: OTHER

Identifier Source: secondary_id

4994

Identifier Type: -

Identifier Source: org_study_id