Influence of Exercise on Neurocognitive Function in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Change in Cognitive Function
研究概览
简要总结
This randomized control trial will examine whether a well-controlled and monitored exercise intervention improves cognitive function in postmenopausal women with early-stage breast cancer and will explore whether neuroimaging metrics of brain health, pro-inflammatory biomarkers and symptoms (fatigue, sleep problems, depression, anxiety) mediate the effects of exercise on cognitive function. Furthermore, the study will explore whether the magnitude of the improvements in cognitive function are modified by estradiol levels.
详细描述
The specific aims include:
- Compared to usual care, examine whether the 6-month exercise intervention improves cognitive function in postmenopausal women with early stage breast cancer.
Hypothesis 1. Exercise will improve cognitive function in women in a domain specific fashion such that attention, executive and memory functions will be influenced more than other domains. 2. Compared to usual care, examine the direct effects of exercise on neuroimaging metrics of brain health including regional gray matter volume, white matter architecture and functional dynamics of the brain and the pro-inflammatory biomarkers (IL-6 as primary outcomes; TNF-α as secondary), and explore the direct effects of exercise on symptoms (fatigue, sleep problems, depression, anxiety).
Hypothesis 2. Exercise will improve neuroimaging metrics of brain health and pro-inflammatory biomarkers. 3. Compared to usual care, explore whether the effects of exercise on cognitive function are mediated by a) neuroimaging metrics of cognitive function, b) IL-6 and TNF-α levels and c) symptoms (fatigue, sleep problems, depression, anxiety), and moderated by E2 levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal female
- •Maximum age 80 years
- •Able to speak and read English
- •Minimum completion of 8 years of education
- •Diagnosed with Stage 0, 1, 2 or 3a Breast Cancer
- •Within 2 years post-completion of primary treatment
- •At least two weeks post-breast conserving surgery or three weeks post-breast conserving surgery with sentinel lymph node biopsy or four weeks post-mastectomy
排除标准
- •Prior treatment with cancer chemotherapy, central nervous system radiation, or intrathecal therapy
- •Clinical evidence of distant metastases
- •Self-report of hospitalization for psychiatric illness within the last two years
- •History of neurologic illness
- •Any of the following breast cancer surgery complications unless approved by the participant's health care provider: persistent seroma requiring aspiration, wound dehiscence, infection, prolonged drain output, lymphedema
- •Reconstructive surgery unless approved by the participant's health care provider
- •Any significant medical condition that would preclude them from exercising (e.g., uncontrolled diabetes, congestive heart failure, angina, uncontrolled arrhythmia or other symptoms that indicate increased risk for an acute cardiovascular or respiratory event) If necessary, we will verify this information with a participant's health care provider
- •Eating disorders or a history of substance abuse
- •Any use of an assisted walking device
- •Recent history of falls or balance problems
- •Additional Exclusion Criteria for Neuroimaging subgroup:
- •Presence of metal implants (i.e., pacemaker, some stents)
研究组 & 干预措施
Usual Care
Physical activity neither limited nor withheld. Participants engage in activity in the same manner as if they were not part of an active intervention.
Moderate-intensity aerobic exercise
Participants engage in a supervised 6-month moderate-intensity aerobic exercise intervention.
干预措施: Moderate-Intensity Aerobic Exercise Intervention (Behavioral)
结局指标
主要结局
Change in Cognitive Function
时间窗: Baseline to 6 months
Cognitive function was assessed with a battery of 14 measures. A data reduction technique, exploratory factor analysis with principal component extraction and varimax (orthogonal) rotation, was used to create summary factors. The cognitive factors identified included processing speed, attention, mental flexibility, working memory, learning and memory, verbal memory, and executive function were derived via this factor analysis. Individual measures with the highest loadings were included in each factor. All measures had factor loadings \>0.400. Scores from the individual measures for each factor were normed based on healthy controls of similar age and education to yield a z-score and these were summed to yield an average z-score for each factor. Z-scores range from -4 to +4, where higher z-scores indicate better performance for each factor.
次要结局
- Fatigue(Baseline and 6 months)
- Sleep Problems(Baseline to 6 months)
- Pro-inflammatory Cytokines(Baseline to 6 months)
- Peak VO2(Baseline and 6 months)
- Anxiety(Baseline to 6 months)
- Depressive Symptoms(Baseline to 6 months)
- Total Brain Size(Baseline and 6 months)
- Estradiol (E2) Levels(Baseline to 6 months)
研究者
Catherine M. Bender, PhD, RN, FAAN
Professor
University of Pittsburgh