[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07447050":3,"trial-entities:NCT07447050":106,"trial-summary:NCT07447050":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":29,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":46,"secondary_outcomes":51,"sex":58,"minimum_age":59,"maximum_age":17,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":78,"locations":81,"central_contacts":91,"overall_officials":99,"references":104,"see_also_links":105},"NCT07447050","STUDY00000370","Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial","RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)","RECRUITING","2028-12-31","2026-02","2026-03-03","2025-12-23","University of California, Irvine","OTHER",true,"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.",null,[19,20,21,22,23,24,25,26,27,28],"Breast Cancer","Sarcoma","Gastric (Stomach) Cancer","Lung Cancer","Head and Neck Cancer","Colorectal Cancer","Ovarian Cancer","Liver Cancer","Genitourinary Cancer","Gynecologic Cancer",[],"INTERVENTIONAL","PREVENTION",[33],"PHASE2",{"count":35,"type":36},24,"ESTIMATED",[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42},"DRUG","Riluzole","Given PO",[40],{"type":14,"name":44,"description":41,"armGroupLabels":45},"Placebo",[44],[47],{"measure":48,"description":49,"timeFrame":50},"Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer patients receiving chemotherapy","Comparing mean plasma BDNF values at each patient visit point, including before the intervention, at subsequent ongoing safety monitoring visits, and at the endpoint of the study.","6 months",[52,55],{"measure":53,"description":54,"timeFrame":50},"Cognitive Function Scores (FACT-Cog)","Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) scores, including both cumulative and perceived cognitive impairment scores. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes.There are four other scoring subscales in FACT-Cog v3: perceived cognitive impairments (PCI; 18 items); perceived cognitive abilities (7 items); impact of perceived cognitive impairment on QOL (4 items); and comments from others on cognitive function (4 items). Both total and PCI scores will be calculated in this study. Total score is calculated by summing scores from all the items and ranges from 0-148, and higher scores represent better subjective cognitive functioning. Similarly, PCI score is calculated by summing responses of all relevant items and ranges from 0 to 72.",{"measure":56,"description":57,"timeFrame":50},"Cognitive Function Scores (CANTAB)","The study will assess the effects of riluzole on cognitive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB) scores across five cognitive domains. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes. Cognitive domains of response speed, learning and memory, working memory, multitasking, and sustained attention will be assessed with CANTAB®. Using International Cognition and Cancer Task Force (ICCTF criteria), overall cognitive impairment is defined as ≥ 2 standard deviations below normative mean on at least 1 cognitive test or ≥ 1.5 standard deviations below normative mean on 2 or more tests.","ALL","18 Years",false,{"inclusion":62,"exclusion":68,"raw_text":77},[63,64,65,66,67],"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.",[69,70,71,72,73,74,75,76],"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\u002Fsubstances 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\u002For 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.","Inclusion Criteria:\n\n* Female and male patients diagnosed with cancer and planned to receive an anthracycline- or platinum- containing chemotherapy regimen.\n* ≥18 years of age.\n* Life expectancy \\> 6 months\n* Able to provide informed consent.\n* 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.\n\nExclusion Criteria:\n\n* Presence of primary brain tumors or brain metastases.\n* Receive a primary chemotherapy regimen that does not include anthracycline- or platinum- containing chemotherapy.\n* Unwilling to undergo neuropsychological assessments necessary for the study.\n* 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.\n* History of or suspected hypersensitivity to riluzole or to any of its excipients.\n* Patients taking or planned to take medications\u002Fsubstances with potential drug-drug interactions: pixantrone, current smoker (defined as having smoked within the last month), abametapir, cannabis, capmatinib, lapatinib, methotrexate, and levoketoconazole.\n* Hepatic impairment as indicated by: AST and\u002For ALT ≥ 3 X upper limit normal (ULN).\n* Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"geoPoint":88},"Chao Family Comprehensive Cancer Center, University of California Irvine","Orange","California","92868","United States",{"lat":89,"lon":90},33.78779,-117.85311,[92,97],{"name":93,"role":94,"phone":95,"email":96},"Chao Family Comprehensive Cancer Center University of California, Irvine","CONTACT","877-827-8839","ucstudy@uci.edu",{"name":98,"role":94},"University of California Irvine Medical",[100],{"name":101,"affiliation":102,"role":103},"Alexandre Chan, PharmD, MPH","Chao Family Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":107,"biomarkers":118},[108,109,110,111,112,113,114,115,116,20,117],"Breast Carcinoma","Colorectal Carcinoma","Gastric Carcinoma","Liver Carcinoma","Lung Carcinoma","Malignant Female Reproductive System Neoplasm","Malignant Genitourinary System Neoplasm","Malignant Head and Neck Neoplasm","Malignant Ovarian Neoplasm","Solid Neoplasm",[],{"nct_id":4,"found":15,"summary":120,"prompt_version":130},{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is a Phase 2a, randomized, double-blinded, placebo-controlled pilot study. It plans to enroll 24 participants.","completed","REFOCUS: Riluzole for Preventing Cognitive Dysfunction in Cancer Patients Receiving Chemotherapy","This study is testing if a drug called Riluzole can help prevent thinking and memory problems (cognitive dysfunction) in people with certain cancers who are receiving chemotherapy. You might be able to join if you are 18 or older, have breast, sarcoma, stomach, lung, or head and neck cancer, and are scheduled to receive specific types of chemotherapy. The study will compare Riluzole to a placebo (an inactive pill) to see if Riluzole changes levels of a brain protein called Brain-Derived Neurotrophic Factor (BDNF) over 6 months. The current recruitment status is unclear.","Changes in BDNF levels will be measured over 6 months.",93,"You would take either Riluzole or a placebo by mouth. You would also need to complete questionnaires and computerized assessments.","Not stated in the trial record.",[40,44],"v2"]