Memantine for Prevention of Cognitive Decline During Adjuvant or Neoadjuvant Chemotherapy in Patients With Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in Visual Working Memory - Delayed Matching to Sample Test
研究概览
简要总结
Purpose: To conduct a one-arm phase II trial to: (1) compare changes in pre- to post-chemotherapy cognitive function in a cohort of patients with breast cancer receiving memantine to historical controls; (2) examine how depression, anxiety, fatigue, baseline Intelligence Quotient (IQ), and cognitive effort relate to objective and self-reported cognitive function; and (3) estimate the feasibility of conducting a clinical trial of memantine for attenuating cognitive decline in patients with breast cancer during chemotherapy.
Participants: Adult patients with stage I-III breast cancer scheduled for adjuvant or neoadjuvant chemotherapy.
Procedures (methods): Cognitive assessments will be performed within one week of initiating and four weeks after completion of chemotherapy. Patients will receive memantine 10 mg twice daily between the pre- and post-chemotherapy study assessments. Cognitive function will be assessed objectively using a computerized cognitive test (Delayed Matching to Sample (DMS) test) and a standard neuropsychological battery. To assess subjective cognitive function, the Patient Reported Outcome Measurement Information System (PROMIS) Cognitive Function measure will be used. Depression, anxiety, fatigue, menopausal status, and sleep will be assessed as covariates.
详细描述
This is a one-arm phase II interventional study in patients with breast cancer to investigate whether memantine can prevent cognitive decline during chemotherapy. The investigators will recruit 56 participants referred to the University of North Carolina (UNC) Breast Center and affiliated outpatient clinics for initiation of adjuvant or neoadjuvant chemotherapy, perform a cognitive assessment within one week of initiating and four weeks after completion of chemotherapy, and treat with memantine 10 mg twice daily between the pre- and post-chemotherapy study assessments (estimated duration: 12-26 weeks, depending on the chemotherapy regimen). Cognitive function will be assessed objectively using a computerized cognitive assessment (Delayed Matching to Sample (DMS) test) and a standard neuropsychological battery. To assess subjective cognitive function, the Patient Reported Outcome Measurement Information System (PROMIS) Cognitive Function measure will be used. Depression, anxiety, fatigue, menopausal status, and sleep are comorbidities known to affect cognitive function, and therefore will be assessed as covariates pre- and post-chemotherapy. Depression, anxiety, health-related quality of life (HRQOL) and functional status will be evaluated as secondary outcomes. The feasibility of the investigator's study by monitoring recruitment, retention, and adherence to memantine will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Able to provide informed consent
- •At least 18 years of age
- •Able to speak English
- •Diagnosed with breast cancer, Stages I-III
- •Scheduled for adjuvant or neoadjuvant chemotherapy
排除标准
- •A history of adverse reaction to memantine
- •Another cancer diagnosis with an estimated survival of less than five years
- •Previous chemotherapy exposure
- •Severe cognitive impairment, defined as Blessed Orientation Memory Concentration Test (BOMC) ≥
- •Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment, or breastfeeding
- •Current alcohol or drug abuse
研究组 & 干预措施
Memantine
Subjects receive memantin
干预措施: Memantine (Drug)
结局指标
主要结局
Change in Visual Working Memory - Delayed Matching to Sample Test
时间窗: From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy
The Delayed Matching to Sample Test (DMS) is a computerized cognitive assessment of visual working memory. The DMS will be administered using Cambridge Neuropsychological Test Automated Battery (CANTAB) eclipse software (Cambridge Cognition, Cambridge, UK). The participant is shown an image with four patterns and asked to match patterns simultaneously or after delay. The investigators will use the percent correct (0 to 100, higher is better) at the 12-second delay on the DMS test for the primary analysis.
次要结局
- Change in Processing Speed and Executive Function - Trail Making Test(From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy)
- Change in Verbal Memory - Hopkins Verbal Learning Test-Revised(From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy)
- Change in Processing Speed - Rapid Visual Processing (RVP)(From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy)
- Change in Attention and Working Memory - Digit Span(From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy)
- Change in Verbal Fluency - Controlled Oral Word Association Test(From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy)
- Change in Executive Function - One Touch Stockings (OTS) of Cambridge(From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy)
- Change in Self-reported Cognitive Function - PROMIS Cognitive Function(From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy)
- Change in Depressive Symptoms - PROMIS Depression(From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy)
- Change in Karnofsky Performance Status(From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy)
- Proportion of Invited Participants Who Enroll - Recruitment(Baseline (pre-chemotherapy) over the duration of the accrual period)
- Proportion of Enrolled Participants Who do Not Meet the Primary Outcome Measure - Attrition(From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy)
- Change in Semantic Fluency - Animal Naming Test(From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy)
- Change in Quality of Life - Functional Assessment of Cancer Therapy-General(From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy)
- Number of Adverse Events - Safety(From baseline to 4 weeks after chemotherapy (up to 30 weeks))
- Change in Anxiety Symptoms - PROMIS Emotional Distress-Anxiety(From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy.)
- Proportion of Scheduled Drug Doses Taken - Adherence(From baseline (pre-chemotherapy) to 4 weeks post-chemotherapy)