Cardiorespiratory Fitness, Inflammatory Biomarkers, and Cognitive Function Patterns During Treatment for Breast Cancer: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fluid Cognition (Composite)
研究概览
简要总结
This study will primarily identify longitudinal associations between cardiorespiratory fitness (CRF) and cognitive function pre- (baseline) to post-chemotherapy (~3 months). This will be a prospective study of 50 BCS. We hypothesize that breast cancer patients undergoing chemotherapy who have higher levels of CRF at baseline will have significantly improved measures of attention, executive function, and memory post-chemotherapy. In addition, the exploratory aims will examine the longitudinal associations between physical activity (PA) and cognitive function from pre- to post-chemotherapy and explore the associations between inflammatory and non-inflammatory biomarkers and CRF with cognitive function.
详细描述
Detailed Description:
Cognitive impairments are reported as a chief quality of life (QoL) complaint by approximately 75% of breast cancer survivors (BCS). Women who have undergone adjuvant chemotherapy are at the highest risk for cognitive impairments, that may affect BCS up to 20 years post-treatment.Despite the prevalence and significance, it is largely underdiagnosed and there are no proven treatments beyond symptom management. Several studies have assessed cognitive function in cancer populations. Increasing evidence highlights the role of lifestyle behaviours on cancer-related outcomes, ranging from QoL to prognosis. However, very few studies have examined the associations of lifestyle factors and cognitive function in BCS.One of the most important mediators of CRCI in BCS may be cardiorespiratory fitness (CRF).
Our overall objective is to examine the behavioral and biological mechanisms that contribute to cognitive decline in BCS undergoing chemotherapy using an epidemiologic, prospective cohort design.
Assessments taken at baseline (pre-chemotherapy) and post-chemotherapy (month 3). Cognitive Function will be assessed using the NIH toolbox cognition battery. Physical Activity. PA will be assessed by accelerometers and through self-report using the Godin-Leisure Time Exercise Questionnaire. Cardiorespiratory Fitness will be assessed using the 6-minute walk test to estimate maximum oxygen uptake (VO2max).Cancer Biomarkers will be assessed using venous blood (2 microtubes) will be drawn from the antecubital vein by a trained phlebotomist. Biological markers analyzed in blood will include a multiplex panel of inflammatory cytokines (i.e., IL1, IL6, TNFα), and brain-derived neurotrophic factor (BDNF).
Our proposed study will be instrumental in designing future targeted translational lifestyle interventions to improve cognitive health in BCS. In addition, understanding the trajectory of cognitive function as it relates to these factors will determine the opportune timeframe to intervene during the cancer care continuum for the greatest impact.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-65 years old
- •histologically-confirmed stage I-III breast cancer, but prior to the initiation of chemotherapy (<1 cycle of adjuvant therapy or neoadjuvant therapy)
- •no diagnosed major cognitive disorders and uncontrolled comorbidities.
排除标准
- •received neoadjuvant chemotherapy and scheduled to receive adjuvant chemotherapy
- •scheduled to receive concurrent radiation therapy with chemotherapy.
结局指标
主要结局
Fluid Cognition (Composite)
时间窗: Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).
Cognitive function will be assessed using the NIH toolbox cognition battery. The NIH toolbox cognition battery with computerized cognitive tasks and automated scoring was used (Weintraub et al., 2013). This composite includes all the tests noted above that are fluid ability measures: Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting and Pattern Comparison. This composite score is derived by averaging the normalized scores of each of the measures, and then deriving scale scores based on this new distribution. An Age-Adjusted Scale Score, Fully Adjusted Scale Score, Unadjusted Scale Score and Age-Adjusted National Percentile are provided for the Fluid Cognition Composite. The Fluid Cognition Composite is a more global assessment of individual and group fluid cognition functioning. Higher scores indicate higher levels of functioning.
次要结局
- Processing Speed (Pattern comparison)(Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).)
- Episodic Memory(Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).)
- Cardiorespiratory fitness(Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).)
- Executive/Shifting(Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).)
- Immediate Recall(Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).)
- Working Memory(Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).)
- Objectively-assessed physical activity(Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).)
- Executive/Attention(Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).)
- Crystallized Cognition(Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).)
- Cancer biomarkers(Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).)
- Language (oral reading)(Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).)
- Language (picture vocabulary)(Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).)
- Processing Speed (oral symbol digit test)(Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).)
- Self-reported physical activity(Change in from baseline (pre-chemotherapy) and post-chemotherapy (month 3).)
研究者
Linda Trinh
Assistant Professor
University of Toronto