High-Intensity Interval Training (HIT) for Breast Cancer Patients During Trastuzumab Use
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Feasibility of utilizing HIT under clinical trial conditions, assessed using participant attendance rate
研究概览
简要总结
This randomized pilot clinical trial studies the feasibility of high-intensity interval training in improving cardiovascular fitness in patients with stage I-III breast cancer undergoing chemotherapy with trastuzumab. Trastuzumab helps patients live longer, but may cause side effects to the heart. Aerobic exercise may help the heart function better, which may help protect it against side effects from trastuzumab. Exercise may also help reduce fatigue and prevent cancer from coming back. High-intensity interval training involves short bursts of higher intensity efforts with longer periods of recovery. This may also allow patients who cannot exercise for a long period of time to still be physically active. This trial studies whether patients can tolerate high-intensity interval training, and how well it works in improving fitness in patients with breast cancer receiving trastuzumab.
详细描述
PRIMARY OBJECTIVES:
I. To assess the feasibility (completion of > 80% exercise sessions) of utilizing high-intensity interval training (HIT).
II. To determine the effects of HIT on aerobic exercise adaptation when compared to delayed group.
III. To examine the effects of HIT on left ventricular function when compared to delayed group.
IV. To determine the effects of HIT on endothelial function, arterial stiffness, and vascular atherosclerosis when compared to delayed group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English or Spanish speaking
- •Diagnosed with early stage (I-III) breast cancer, without evidence of metastatic disease
- •Planned (neo)adjuvant therapy with trastuzumab (Herceptin) and/or anthracycline-based chemotherapy
- •Not currently pregnant or planning to become pregnant throughout the duration of cancer treatment
- •Physician (oncologist) clearance to participate in exercise at moderate to high intensity
- •Have read and signed study informed consent document (ICF)
- •EXERCISE INCLUSION CRITERIA:
- •Normal body temperature (=< 100 degrees F)
- •Resting blood pressure and/or heart rate within normal limits
- •Participants have not received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session
排除标准
- •Advanced stage (stage IV) or metastatic breast cancer diagnosis (screening for metastases with scans only needed if there is clinical suspicion for metastases)
- •Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
- •Uncontrolled hypertension or other uncontrolled chronic disease (e.g. diabetes mellitus, thyroid disease, pulmonary disease, etc.)
- •Moderate to highly active level of physical activity (e.g. currently participating in >= 60 minutes of moderate aerobic activity weekly)
- •Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise
- •EXERCISE EXCLUSION CRITERIA:
- •Presence of fever (>= 100 degrees F)
- •Resting blood pressure and/or heart rate outside normal limits
- •Participants have received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session
结局指标
主要结局
Feasibility of utilizing HIT under clinical trial conditions, assessed using participant attendance rate
时间窗: Up to 17 weeks
The exercise program will be considered feasible if participants complete greater than 80% of exercise sessions. Participant attendance rates will be used to establish compliance and will be used to provide a perspective on how and to what extent cancer patients will participate in an experimental exercise intervention and what variations in exercise intensities may be tolerated. Feasibility will be assessed based on both program attendance as well as exercise time completed.
次要结局
- Change in aerobic exercise adaptation measured by the maximum volume of oxygen uptake (VO2peak) (ml/kg/min)(Baseline to up to week 17)
- Change in left ventricular function(Baseline to up to week 17)