Sign in
Taking people in United StatesPhase 2

Testing Riluzole for Thinking Problems After Cancer Treatment

Tests riluzole against placebo in adults with cancer-related thinking problems.

Key facts

Who runs it
University of California, Irvine
Where
Orange, United StatesSee the site
Trial code
Registry title
Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial
Status
Recruiting
Phase
Phase 2
People taking part
75 people, planned
Started
2 Dec 2024
Expected to end
Dec 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Riluzole
  • Placebo
Record updated
14 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who feel their thinking has worsened after cancer treatment or after radiation to the brain. They would take riluzole or a placebo.

Age
18 years or older
Sex
Men and women can join.
Disease stage
Cohort A: breast cancer treated in any way, or other cancers treated with chemotherapy or other anticancer therapy within the past 3 years, with no earlier radiation to the head. Cohort B: earlier radiotherapy or radiosurgery to the brain for a benign, malignant or spread tumor, and life expectancy over 6 months.
Earlier treatment
Cohort A: cancer treatment, for non-breast cancers within the past 3 years. Cohort B: earlier radiation to the brain. Time off other treatments is up to the investigator.

Main reasons for not taking part

  • Cohort A: current or past primary brain tumor or brain metastases
  • Cohort B: high grade glioma
  • Pregnant or breastfeeding women, or women planning to become pregnant during the study
  • Known allergy to riluzole or its ingredients
  • Liver problems (AST or ALT 3x the upper limit of normal or more)

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Cohort-specific inclusion for male and female patients; Cohort A (no prior cranial radiation) i. Diagnosed with one of the following:; Breast cancer exposed to treatment including chemotherapy, radiotherapy, surgery and/or other breast cancer interventions; Non-breast cancer patients exposed to anthracyclines- or platinum-containing chemotherapy within the past 3 years; Non-breast cancer patients exposed to other anticancer therapies within the past 3 years; Cohort B (prior cranial radiation); Previously received radiotherapy or radiosurgery to the brain for benign, malignant, or metastatic tumors; Life expectancy > 6 months
  • Washout from investigational and conventional 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 receipt of cranial radiation or 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

Who cannot take part

  • Cohort-specific exclusion for male and female patients:; Cohort A (no prior cranial radiation); History of or current presence of primary brain tumors or brain metastases; Cohort B (prior cranial radiation); Diagnosed with high grade glioma
  • 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
  • Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Persons of child-bearing potential (POCBP) must have a negative pregnancy test at screening if there is suspicion of pregnancy; 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
  • Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study
  • Hepatic impairment as indicated by: AST or ALT ≥ 3x upper limit normal (ULN)
  • Unwilling to undergo neuropsychological assessments necessary for the study

Where in United States

  • Chao Family Comprehensive Cancer Center, University of California, IrvineOrange, United StatesContact: Alexandre Chan, PharmD, MPHTaking people

About the trial

What the trial wants to find out

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 in cancer survivors (recently completing prior treatment regimens) or patients who have received whole brain radiation for benign or malignant tumors with cancer related cognitive impairment.

The 2 groups in the trial

  • RiluzoleTreatment being tested

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

  • PlaceboPlacebo, for comparison

    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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Repurposing Riluzole for Augmenting Brain-Derived Neuropathic Factor (BDNF) Levels and Cognitive Function in Patients Experiencing Cancer-Related Cognitive Impairment: An Interventional Pilot Clinical Trial
Plain-language title
Testing Riluzole for Thinking Problems After Cancer TreatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
14 July 2026