Pilot Feasibility Study of the Use of Random Periareolar Fine Needle Aspiration Exercise Induced Changes in Breast Tissue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Feasibility of enrolling patients in a study looking at the impact of exercise upon breast tissue markers
研究概览
简要总结
This study is being done to see if the investigators can measure changes that occur in breast tissue when women at risk of developing breast cancer start an exercise program. The investigators are interested in studying this because research shows that women who exercise regularly are less likely to develop breast cancer, but there is not very much information explaining how exercise could affect breast cells in a way to prevent cancer from occurring. In this research study the investigators will use a research technique called breast random fine needle aspiration (RPFNA) to test breast cells for their shape and how they look. The investigators will look at breast cells before and after a participant takes part in an exercise program to see if the investigators are able to see any changes in breast cells that could have happened due to the exercise program. This research will help us to develop larger projects to see if exercise programs could be helpful in preventing breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •History of lobular carcinoma in situ, atypical ductal/lobular hyperplasia on prior breast biopsy or lifetime risk of breast cancer of at least 20% based on any risk model, or personal history of BRCA1 or 2 mutation
- •Physically able to exercise and physician consent to start an exercise program
- •Sedentary activity pattern
- •Premenopausal
- •English speaking and able to read English
排除标准
- •History of invasive breast cancer or ductal carcinoma in situ
- •Absolute contraindications to maximal exercise testing as recommended by the American Thoracic Society
- •Any condition which in the investigator's opinion makes the subject unsuitable for study participation
- •Participating in another clinical study with competing study outcomes
- •Pregnant or breastfeeding
- •Unable to comply with protocol and/or not available for follow-ups
- •Type II Diabetes
- •Allergic to local anesthetics
- •History of bilateral or unilateral mastectomy
研究组 & 干预措施
Exercise Intervention
220 minutes of exercise per week, including 2-3 supervised sessions for 6 weeks
干预措施: Exercise Intervention (Behavioral)
结局指标
主要结局
Feasibility of enrolling patients in a study looking at the impact of exercise upon breast tissue markers
时间窗: 2 years
This is a small pilot feasability study designed to see if we can recruit patients into this kind of trial and if we can measure biomarker expression in breast tissue collected through RPFNA. Data analyses will be primarily descriptive in this pilot study. The primary feasibility endpoint will be assessed by the number of women with pre- and post-exercise RPFNA samples with sufficient cells (\> 500) for analysis. We require evidence that at least 60% of participants could provide adequate samples order to declare success in this pilot study. Therefore, if 10 of 12 enrolled women have RPFNA samples at both times with sufficient cells, the lower bound of the one-sided, 90% exact confidence interval will exceed 60% and the study will be considered feasible.
次要结局
- Secondary objectives will explore changes in proliferative and morphologic indices of the breast as expressed by changes in Ki-67 and the Masood index.(2 years)
研究者
Jennifer A. Ligibel, MD
Principal Investigator
Dana-Farber Cancer Institute