LCCC 1410: Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- To measure the change in level of p16 expression from baseline to end of chemotherapy to a control group
研究概览
简要总结
To determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age.
详细描述
LCCC1410 is designed to compare the change in p16 from baseline to end of chemotherapy in 100 older (≥ 65 years) breast cancer patients participating in a home-based physical activity program (intervention group) to 100 patients in the concurrent control group not participating in a physical activity intervention (enrolled in a separate RO1 study as described in section 1.7). The biomarker p16 is known to dramatically increase with chemotherapy, and we hypothesize that the increase will be attenuated by a physical activity intervention. We will evaluate changes in p16 between the two study populations. Data from the geriatric assessment at baseline will be used to characterize the study population, and subscale scores from the GA will also be assessed for differences between baseline and end of chemotherapy to compare the LCCC1410 study population with the concurrent control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 65 or older, female
- •Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
- •Scheduled to begin an appropriate adjuvant or neoadjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org)
- •English speaking
- •IRB approved, signed written informed consent
- •Approval from their treating physician to engage in moderate-intensity physical activity
- •Patient-assessed ability to walk and engage in moderate physical activity
- •Willing and able to meet all study requirements.
排除标准
- •One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.
结局指标
主要结局
To measure the change in level of p16 expression from baseline to end of chemotherapy to a control group
时间窗: 12 months
The comparison group will be taken from another study
To measure the changes in the level of p16 expression from baseline and end of chemotherapy.
时间窗: 2 - 6 months
The study will look at the change of p16 expression within patients on this study.
次要结局
- To measure change in physical function over the course of the study(12 months)
- To measure changes in body compositional aspects of lean body mass (LBM)(12 months)
- To measure changes in body compositional aspects of fat tissue mass (FM)(12 months)
- To measure changes in body compositional aspects of percentage body fat (BF)(12 months)
- To measure change in physical activity over the course of the study(12 months)
- To measure retention during the study(12 months)
- To measure safety of the walking program(12 months)
- To measure change in fatigue over the course of the study(12 months)
- To measure change in self-efficacy over the course of the study(12 months)
- To average the number of daily and weekly steps per participant(12 months)
- To measure change in quality of life over the course of the study(12 months)
- To measure overall satisfaction with the program(12 months)