Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:43 AM
Study NCT ID:
NCT07447050
Status:
RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019782', 'term': 'Riluzole'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D052160', 'term': 'Benzothiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer patients receiving chemotherapy', 'timeFrame': '6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Cognitive Function Scores (FACT-Cog)', 'timeFrame': '6 months', 'description': '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': 'Cognitive Function Scores (CANTAB)', 'timeFrame': '6 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Sarcoma', 'Gastric (Stomach) Cancer', 'Lung Cancer', 'Head and Neck Cancer', 'Colorectal Cancer', 'Ovarian Cancer', 'Liver Cancer', 'Genitourinary Cancer', 'Gynecologic Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/substances 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/or 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."}, 'identificationModule': {'nctId': 'NCT07447050', 'briefTitle': 'Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)', 'orgStudyIdInfo': {'id': 'STUDY00000370'}, 'secondaryIdInfos': [{'id': 'UCI 25-48', 'type': 'OTHER', 'domain': 'UCI CFCCC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Riluzole', 'description': 'Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for up to 6 months', 'interventionNames': ['Drug: Riluzole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Riluzole', 'type': 'DRUG', 'description': 'Given PO', 'armGroupLabels': ['Riluzole']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Given PO', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Chao Family Comprehensive Cancer Center, University of California Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'centralContacts': [{'name': 'Chao Family Comprehensive Cancer Center University of California, Irvine', 'role': 'CONTACT', 'email': 'ucstudy@uci.edu', 'phone': '877-827-8839'}, {'name': 'University of California Irvine Medical', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Alexandre Chan, PharmD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chao Family Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department Chair & Professor of Clinical Pharmacy', 'investigatorFullName': 'Alexandre Chan', 'investigatorAffiliation': 'University of California, Irvine'}}}}