RiluzolE FOr Preventing Cognitive DysfUnction in Cancer PatientS Receiving Chemotherapy (REFOCUS)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer patients receiving chemotherapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Riluzole
Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for up to 6 months
干预措施: Riluzole (Drug)
Placebo
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
干预措施: Placebo (Other)
结局指标
主要结局
Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer patients receiving chemotherapy
时间窗: 6 months
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.
次要结局
- Cognitive Function Scores (FACT-Cog)(6 months)
- Cognitive Function Scores (CANTAB)(6 months)
研究者
Alexandre Chan
Department Chair & Professor of Clinical Pharmacy
University of California, Irvine