Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Rates of recruitment
研究概览
简要总结
This randomized, placebo-controlled trial aims to assess the feasibility, acceptability, and preliminary efficacy of memantine and the University of Carolina (UNC)'s Get Real & Heel cancer exercise program (MEM+EX) in addressing cancer-related cognitive impairment (CRCI) and underlying CRCI biomarkers. Ninety stage I-III breast cancer patients during chemotherapy will be randomized into three groups: MEM+EX, memantine, or placebo. The study will evaluate recruitment, retention, adherence, acceptability, cognitive function, brain-derived neurotrophic factor (BDNF), inflammatory markers, and frailty at multiple time points.
详细描述
There are 4 million breast cancer survivors in the U.S. and an estimated 1.4 million suffer from long-term cognitive deficits from cancer treatment. Compared to other cancers and treatments, cognitive decline has been most robustly described in breast cancer and following chemotherapy with up to 75% self-reporting and ~50% objectively demonstrating at least mild cognitive deficits after chemotherapy. Memantine, an N-methyl-D-aspartate receptor antagonist, is a promising medication to address underlying mechanisms of CRCI, including inflammation and pathways involving brain-derived neurotrophic factor (BDNF). Exercise, a promising intervention for frailty which intervenes on multiple mechanisms of aging, is an ideal strategy to augment the targeted effects of memantine.
The primary objective of this study is to demonstrate the feasibility and acceptability of MEM+EX during breast cancer chemotherapy. Secondarily, the preliminary efficacy of MEM+EX and memantine on putative biomarkers of CRCI and cognitive function will be evaluated. Furthermore, the impact of frailty on the preliminary efficacy of MEM+EX and memantine will be explored.
The proposed study has the potential to produce significant public health benefit by filling a major gap in effective CRCI treatments. It will provide important pilot data for future, definitive randomized controlled studies. Finally, this study will advance understanding of potential targets to pursue in future cognitive interventions, including pathways involving BDNF and inflammation, during treatment for cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In order to participate in the study a subject must meet all of the eligibility criteria outlined below.
- •Age ≥ 18 years at the time of consent.
- •Stage I-III Breast Cancer
- •Recommended chemotherapy
- •Enroll prior to 3rd cycle of chemotherapy
- •English-speaking
排除标准
- •Allergy to memantine
- •Previous chemotherapy (prior to the current regimen),
- •Severe cognitive impairment, defined by Blessed Orientation Memory Concentration Test Score ≥11
- •Myocardial infarction in the last 6 months
- •Cardiovascular or orthopedic limitations to exercise
- •Severe mental illness (i.e., schizophrenia or bipolar affective disorder)
- •Current alcohol or drug abuse
- •Inability to swallow capsules </= 5mL/min
- •CrCl </= 5mL/min
研究组 & 干预措施
Arm 3
Participants will receive study medication (memantine) and access to a library of pre-recorded Get Real & Heel sessions.
干预措施: Memantine (Drug)
Arm 1
Participants will receive study medication (memantine) and Get Real & Heel exercise guided by the therapist.
干预措施: Memantine (Drug)
Arm 1
Participants will receive study medication (memantine) and Get Real & Heel exercise guided by the therapist.
干预措施: Exercise Intervention (Other)
Arm 2
Participants have access to a library of pre-recorded Get Real & Heel sessions.
干预措施: Placebo medication (Drug)
Arm 3
Participants will receive study medication (memantine) and access to a library of pre-recorded Get Real & Heel sessions.
干预措施: Exercise Control (Other)
Arm 2
Participants have access to a library of pre-recorded Get Real & Heel sessions.
干预措施: Exercise Control (Other)
结局指标
主要结局
Rates of recruitment
时间窗: Baseline
Rates of recruitment will be measured as a number of subjects joined the study.
Rates of retention
时间窗: Up to a year
Rates of retention will be measured as the proportion of subjects who remained in the study at post-intervention (up to 6 months) and after 6 months among those who started the intervention
Rates of adherence
时间窗: Up to a year
Rates of adherence will be measured as a number of subjects who joined the study completed 80 percent of planned study activities.
The acceptability of memantine + Get Real and Heel (MEM+EX)
时间窗: Up to 6 months
The acceptability of memantine + Get Real and Heel (MEM+EX) will be assessed using the Client Satisfaction Questionnaire (CSQ-3). CSQ-3 is a three-item measure of treatment acceptability that has demonstrated excellent reliability and validity across a range of patient care settings. Each item is scored on a Likert-type scale from 1 (low satisfaction) to 4 (high satisfaction). CSQ-3 will be completed at post-intervention only (or at the time of withdrawal from the study, if applicable).
次要结局
- Attention and Executive Function Composite Score(Baseline and up to 1 year)
- Learning and Memory Composite Score(Baseline and up to 1 year)
- The impact of MEM+EX and memantine on brain-derived neurotrophic factor (BDNF)(Baseline and up to 6 months)
- Changes in patient-reported cognition(Baseline and up to 1 year)
- The impact of MEM+EX and memantine on inflammatory markers(Baseline and up to 6 months)