Recruiting
Phase 2

Riluzole

Sponsor:

UCLA

Code:

NCT07447050

Conditions

Breast Cancer

Sarcoma

Gastric (Stomach) Cancer

Lung Cancer

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Riluzole

Placebo

Study Details

Brief summary:

This is a phase II single-arm, Phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining efficacy of riluzole in preventing cognitive dysfunction in subjects with cancer, who are receiving chemotherapy.

Conditions

Breast Cancer

Sarcoma

Gastric (Stomach) Cancer

Lung Cancer

Head and Neck Cancer

Study ID

NCT07447050

Start date

Dec 23, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female and male patients diagnosed with cancer and planned to receive an anthracycline- or platinum- containing chemotherapy regimen.
  • ≥18 years of age.
  • Life expectancy > 6 months
  • Able to provide informed consent.
  • 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 primary brain tumors or brain metastases.
  • Receive a primary chemotherapy regimen that does not include anthracycline- or platinum- containing chemotherapy.
  • Unwilling to undergo neuropsychological assessments necessary for the study.
  • Patients who are breastfeeding, pregnant or are planning to get pregnant during the study period. POCBP must have a negative pregnancy test at screening if there is suspicion of pregnancy. 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 or 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 and/or ALT ≥ 3 X 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

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Riluzole

Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for up to 6 months

placebo comparator: 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 up to 6 months

Interventions

Riluzole

Given PO

Placebo

Given PO

Primary outcome measure

  • Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer patients receiving chemotherapy [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

877-827-8839ucstudy@uci.edu

Locations

Chao Family Comprehensive Cancer Center, University of California Irvine

Recruiting

Orange, California, United States, 92868

More Information

Sponsor

University of California, Irvine

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-03-03.