Potential Effect of Vortioxetine on Cognitive Functioning of Patients With ALK-positive Non-Small Cell Lung Cancer Treated With Lorlatinib
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
研究概览
简要总结
This observational study evaluates whether vortioxetine - an antidepressant medication with cognitive-enhancing properties - can reduce the neurological and cognitive side effects associated with lorlatinib treatment in patients with non-small cell lung cancer (NSCLC) harboring ALK or ROS1 gene rearrangements.
Lorlatinib is a highly effective third-generation tyrosine kinase inhibitor, but it causes neuropsychological adverse events (NAEs) in approximately 42% of patients, including cognitive impairment, mood changes, and speech disturbances. Vortioxetine has demonstrated cognitive improvement in depressed patients and in preclinical models of androgen deprivation therapy-induced cognitive impairment.
Twenty-four adult patients with ALK/ROS1-positive NSCLC receiving lorlatinib as standard care and prescribed vortioxetine (10-20 mg/day) for NAE management will be enrolled. Comprehensive neuropsychological assessments and quality-of-life questionnaires will be conducted at baseline, week 6, week 12, and month 6 to document changes in cognitive function, depressive symptoms, and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Histologically confirmed diagnosis of ALK/ROS1-positive non-small cell lung cancer (NSCLC), stage IIIB/IV.
- •Currently receiving lorlatinib as part of the standard therapeutic regimen.
- •Documented neurocognitive adverse events (NAEs) attributable to lorlatinib.
- •Age >= 18 years.
- •ECOG performance status 0-
- •Ability to understand and sign informed consent.
- •Expected survival >= 6 months.
- •Planned initiation of vortioxetine as part of standard care.
- •Ability to complete neuropsychological tests and questionnaires in Spanish.
排除标准
- •Prior diagnosis of major cognitive impairment unrelated to cancer treatment.
- •Current use of another antidepressant that cannot be discontinued.
- •Uncontrolled major psychiatric disorder.
- •History of uncontrolled epilepsy or recent seizures.
- •Severe hepatic or renal impairment.
- •Known hypersensitivity to vortioxetine.
- •Participation in another clinical trial within the past 30 days.
- •Inability to provide informed consent.
- •Life expectancy < 3 months.
- •Contraindications to vortioxetine (e.g., concomitant MAOI use).
- •Prior vortioxetine use.
- •Severe psychiatric disorders or significant cognitive impairment unrelated to lorlatinib.