Recruiting NCT07447050
Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Riluzole, Placebo.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Sarcoma, Gastric (Stomach) Cancer, Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)
Overview
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.
Interventions
- Drug Riluzole
Given PO - Other Placebo
Given PO
Primary outcome measures
- Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer patients receiving chemotherapy [Time frame: 6 months]
Secondary outcome measures (2)
- Cognitive Function Scores (FACT-Cog) [Time frame: 6 months]
- Cognitive Function Scores (CANTAB) [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Chao Family Comprehensive Cancer Center, University of California Irvine — Orange
Identifiers
NCT: NCT07447050 · STUDY00000370 · UCI 25-48