Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Change in Irisin in Exercise Group
研究概览
简要总结
The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer in women with dense breast tissue by studying changes that occur in breast tissue and blood as a result of participating in an exercise program.
The names of the study groups in this study are:
- Exercise Training Group
- Waitlist Control Group
详细描述
The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer by studying changes that occur in breast tissue and blood as a result of participating in an exercise program. Participants will be placed into one of two study groups: Exercise Training Group vs. Waitlist Control Group. Randomization means that a participant is put into a group by chance.
The research study procedures include screening for eligibility and baseline and end of study assessments which include: breast biopsies, assessment of physical activity habits, aerobic and strength testing, blood draws and questionnaires.
Participants randomized to the exercise group will be expected to participate in exercise sessions throughout the study. They will also be asked to complete logs of their activity.
Participants will be in this research study for up to 16 weeks.
It is expected that 46 women will take part in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-59
- •Heterogeneously dense/extremely dense (BIRADS 3 or 4) breast tissue on mammogram within the past 12 months
- •Physically inactive; engaging in <60 minutes of moderate or vigorous intensity exercise per week, as assessed by Godin Leisure Time screener
- •Not pregnant or breastfeeding
- •English speaking and able to read English. Investigators are only enrolling English-speaking participants to this study at this time due to the fact that investigators currently only have English-speaking exercise trainers with the proper qualifications to conduct the exercise training
- •Written informed consent prior to any study-related procedures
排除标准
- •Self-reported inability to walk 2 blocks (at any pace)
- •Prior history of breast cancer; prior DCIS is allowable as long as participant is not taking endocrine therapy and has at least 1 breast that has not been irradiated
- •On oral or implantable hormonal contraceptives, postmenopausal hormone replacement therapy, a selective estrogen receptor modulator or an aromatase inhibitor; Mirena or other IUD is acceptable
- •Consistent strength training in the past 3 months
- •Use of weightloss drugs
- •Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate exercise. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility
- •Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder)
结局指标
主要结局
Change in Irisin in Exercise Group
时间窗: At baseline, within 2 hours of 1st exercise session, and at week 12, up to 16 weeks
Change in circulating irisin at baseline, after 1st exercise session, and end of study in exercise group, and it will be compared using Wilcoxon rank-sum testing. Irisin will be measured by Parallel Reaction Monitoring in the Spiegelman Lab, using the method described by Jedrychowski.
Change in Irisin in Control Group
时间窗: At baseline and week 12, up to 16 weeks
Change in circulating irisin at baseline and end of study in control group, and it will be compared using Wilcoxon rank-sum testing. Irisin will be measured by Parallel Reaction Monitoring in the Spiegelman Lab, using the method described by Jedrychowski.
次要结局
- Change in Tissue Markers in Control Group(At baseline and week 12, up to 16 weeks)
- 10-Repetition Max Test in Control Group(At baseline and week 12, up to 16 weeks)
- Change in Minutes of Total Exercise for Exercise Group(Up to 16 weeks)
- Change in Tissue Markers in Exercise Group(At baseline and week 12, up to 16 weeks)
- Change in Biomarkers in Control Group - Meso Scale(At baseline and week 12, up to 16 weeks)
- Change in Cardiorespiratory Fitness in Control Group(At baseline and week 12, up to 16 weeks)
- 10-Repetition Max Test in Exercise Group(At baseline and week 12, up to 16 weeks)
- Change in Biomarkers in Exercise Group - Mass cytometry(At baseline and week 12, up to 16 weeks)
- Change in Biomarkers in Control Group - Mass cytometry(At baseline and week 12, up to 16 weeks)
- Change in Participant Weight in Control Group(At baseline and week 12, up to 16 weeks)
- Change in Biomarkers in Exercise Group - Meso scale(At baseline and week 12, up to 16 weeks)
- Change in Participant Weight in Exercise Group(At baseline and week 12, up to 16 weeks)
- Change in Minutes of Total Exercise for Control Group(Up to 16 weeks)
- Change in Cardiorespiratory Fitness in Exercise Group(At baseline and week 12, up to 16 weeks)
研究者
Jennifer A. Ligibel, MD
Principal Investigator
Dana-Farber Cancer Institute