Women In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Changes in deoxy-hemoglobin
研究概览
简要总结
The primary aim is to examine changes in tumor perfusion, oxygen saturation, and tumor physiology before and following acute physical activity in breast cancer patients.
The secondary aim is to examine changes in circulating tumor DNA (ctDNA) levels before and following acute physical activity in breast cancer patients.
The tertiary aim is to explore changes in circulating exerkines (cytokines and growth factors altered by exercise) before and following acute physical activity in breast cancer patients.
详细描述
The proposed study seeks to leverage acute exercise physiology as a tool to better understand multiple clinical and mechanistic issues in exercise oncology. An acute exercise bout causes functional changes such as increases in heart rate and stroke volume leading to increased cardiac output and increased systemic blood flow. These systemic effects also increase tumor blood flow (perfusion). Additionally, an increase in mean arterial pressure increases oxygen diffusion distance within the tumor. Further, acute exercise mobilizes NK cells, cytokine signaling, and a myriad of other molecular and cellular transducers of exercise. Our study of acute exercise physiology in breast cancer patients will address several significant knowledge gaps both clinically and mechanistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed breast cancer patients
- •Breast tumor is more than 2 cm (T2)
- •With or without lymph node involvement (N0-3)
- •With or without metastases (M0-M1)
- •No initiation of neoadjuvant treatment
- •Pre-surgical breast resection
排除标准
- •Current use of anticoagulants, including Vitamin K antagonists (e.g. Warfarin), Direct Oral Anticoagulants (DOACs) (e.g. Pradaxa, Eliquis, Xarelto, Bevyxxa, Savaysa), low molecular weight heparins (LMWH), Fragmin, Lovenox, heparin.
- •Body weight <100 lbs
- •Tis, T0, T1
- •Started neoadjuvant therapy
- •Absolute contraindications for exercise stress testing by self-report:
- •acute myocardial infarction (3-5 days)
- •unstable angina
- •uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- •acute endocarditis
- •acute myocarditis or pericarditis
- •uncontrolled heart failure
- •acute pulmonary embolus or pulmonary infarction
- •thrombosis of lower extremities
- •suspected dissecting aneurysm
- •uncontrolled asthma
- •pulmonary edema
- •room air desaturation at rest ≤85%
- •respiratory failure
- •acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
- •mental impairment leading to inability to cooperate
- •decisional impairment
- •Non-English speaking
- •Pregnant women
结局指标
主要结局
Changes in deoxy-hemoglobin
时间窗: baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET
Deoxy-hemoglobin will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.
Changes in total hemoglobin
时间窗: baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET
Total hemoglobin will be quantified using photoacoustic imaging and the % difference will be determined 1) before cardiopulmonary exercise (CPET) (Time 0), 2) immediately after CPET (Time 1), 3) 30 min after CPET (Time 2) , and 4) 2 hours after CPET (Time 3).
Changes in oxy-hemoglobin
时间窗: baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET
Oxy-hemoglobin will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.
Changes in oxygen saturation
时间窗: baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET
Oxygen saturation will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.
次要结局
- Exerkine: S1P(baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET)
- Exerkine: TSP-1(baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET)
- Changes in ctDNA level(baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET)
- Exerkine: TGF-β(baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET)
- Exerkine: VEGF-A(baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET)
研究者
Kathleen Sturgeon
Assistant Professor
Milton S. Hershey Medical Center