Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial
RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether riluzole can prevent problems with memory and thinking during chemotherapy. It is for adults with cancer who will receive chemotherapy that includes an anthracycline or platinum drug.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have cancer and plan to receive chemotherapy that includes an anthracycline or platinum drug.
- Be age 18 or older.
- Be expected to live more than 6 months.
- Be able to understand the study and agree to take part.
- Agree to and be able to complete surveys and computer tests. People with vision problems or conditions such as Parkinson’s disease may skip computer tests if they can complete surveys with help.
Who can't join
- Have a tumor that started in the brain or cancer that has spread to the brain.
- Receive a main chemotherapy treatment that does not include an anthracycline or platinum drug.
- Be unwilling to take the study’s thinking and memory tests.
- Be breastfeeding, pregnant, or planning pregnancy during the study. If pregnancy is possible and suspected, a negative pregnancy test is needed. People considered unable to become pregnant must have had no periods for at least 1 year after menopause, had their tubes tied, or had their uterus removed.
- Have a known or suspected allergy to riluzole or any of its ingredients.
- Have smoked within the past month, or take or plan to take any of these: pixantrone, abametapir, cannabis, capmatinib, lapatinib, methotrexate, or levoketoconazole.
- Have liver blood test results called AST or ALT that are at least 3 times the upper normal limit.
- Have a serious existing health problem that the study doctor believes would prevent taking part.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
CA
- Chao Family Comprehensive Cancer Center, University of California Irvine · Orange, CA 92868More trials in Orange