A Randomized Control Trial of the Efficacy of a Cardio-Oncology Rehabilitation Exercise Program to Improve Cardiorespiratory Fitness in Women With Breast Cancer and Treatment Related Cardiotoxicity (CORE Study).
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Cardiopulmonary Fitness
研究概览
简要总结
Breast cancer is the leading cause of cancer among Canadian women with nearly 26,000 new cases diagnosed each year. Fortunately, advancements in diagnostic tools and curative treatments have significantly improved overall survival. However, the development of cardiac toxicity (including asymptomatic and symptomatic heart failure) associated with use of anthracycline containing chemotherapy and targeted therapies including trastuzumab limits improvements in survival for women with breast cancer. Cardiac toxicity is a life threatening complication that leads to reduced physical functioning and quality of life. The increased risk is associated with shared risk factors among cancer and heart failure and the direct influence of cancer therapy on the cardiovascular system. Cardiac rehabilitation (CR) (including exercise training and education/counselling) has been shown to improve health outcomes, reduce heart failure related hospitalizations and modestly improve mortality among individuals with non-treatment related heart failure and may benefit women with breast cancer and treatment related cardiac toxicity (BC-CT). Therefore, this single centre, randomized control trial aims to determine if participation in an exercise based CR program can improve cardiorespiratory fitness, cardiovascular function/structure and health, and quality of life among women with BC-CT.
详细描述
Study Design: A single centre, two-arm, parallel group with standard of care controlled superiority trial with a balanced (1:1) block randomization will be conducted at the Toronto Rehabilitation institute, Toronto Canada. A total of 38 women (19 participants per study arm) with BC-CT presenting at Cardiology Clinics in Toronto Canada will be enrolled. After baseline assessments, eligible participants will be randomized to one of two arms including the exercise rehabilitation program or the control group (no exercise training intervention).
Patient Population: Women with BC-CT (defined as a decrease in the left ventricular ejection fraction of >10 percentage points, to a value <53% by 2D-echocardiography or a diagnosis of heart failure) who are undergoing therapy with anthracyclines and/or trastuzumab.
Procedures: The following measurements will be collected at the beginning and following the 12 week intervention. Participants will also be expected to attend one weekly exercise session at the Toronto Rehabilitation institute each week, and will be expected to complete additional exercise training sessions at home or in the community each week.
Day 1: All participants will then undergo baseline assessments at the Toronto Rehabilitation Institute including a cardiopulmonary exercise test to assess VO2peak. Resting and exercise haemodynamic outcomes, VO2peak achieved, symptoms, and reason for test termination will also be collected. Standard measures conducted during the intake process including height, weight, body fat percent, and waist circumference will also be collected. The participants will be provided with a blood requisition form that will be returned during the first week of class. The questionnaires for physical activity patterns (Godin Leisure Physical Activity Questionnaire), quality of life, a health history questionnaire, as well as the activity tracking devices will also be administered by the research coordinator upon their initial visit.
Day 2: All cardiac assessments will be conducted on a separate day of testing at Toronto General Hospital by a skilled clinical cardiac sonographer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Women with breast cancer (receptor status: human epidermal growth factor receptor (HER2+/-), Progesterone receptor, (PR+/-), estrogen receptor (ER+/-); Stage I-III)
- •Are 18 yrs. of age or older
- •A diagnosis of cardiac toxicity that occurred during treatment will be defined as a decrease from baseline in the left ventricular ejection fraction of >10 percentage points, to a value < 53% by 2D-echocardiography upon repeated measures or a diagnosis of heart failure which will be confirmed by the cardiologist upon cardiac evaluation
- •Currently undergoing known cardiotoxic agents including the HER2-antagonist trastuzumab and/or chemotherapy agents including doxorubicin and epirubicin
排除标准
- •Women who are pregnant
- •Treated with a left ventricular assistant device or a pacemaker.
- •Have metastatic disease
- •Previous exposure to anthracyclines, cytotoxic treatments or radiation preceding their breast cancer diagnosis
- •Unable to confirm a diagnosis of heart failure due to treatment for breast cancer upon cardiac evaluation by their Cardiologist
- •Myocardial infarction, complex arrhythmias, or unstable cardiac symptoms in the previous six weeks prior to study enrolment
- •Significant co-morbidities that limit their ability to perform exercise (i.e., severe peripheral artery disease, severe chronic obstructive pulmonary disease, musculoskeletal injury or stroke)
- •Contraindications to exercise training identified on their first cardiopulmonary assessment that do not subside prior to beginning the program including angina pectoris symptoms, light-headedness or dizziness with exercise, and resting blood pressure > 200mmHg systolic or >120mmHg diastolic blood pressure.
- •Contraindications to resistance training including increased eye pressures (> 20mmHg), untreated hernias, limitations due to surgery (lumpectomy/mastectomy) and potential musculoskeletal injuries
研究组 & 干预措施
Exercise Rehabilitation
The intervention group will participate in the exercise rehabilitation program for a total of 12 weeks. This includes performing aerobic training five times per week and resistance training two to three times per week. Participants will also be expected to attend the education sessions following their supervised exercise rehabilitation sessions each week.
干预措施: Exercise Rehabilitation (Other)
Usual Care
Participants in the control group will be encouraged to continue with their regular physical activity routine and will receive regular standard of care by their Cardiologist and Oncologist.
结局指标
主要结局
Cardiopulmonary Fitness
时间窗: Baseline and 12 weeks
A cardiopulmonary exercise test will be completed following the Bruce or modified Bruce protocol. Breath-by-breath gas samples will be collected and averaged over a 20-second period using a calibrated metabolic cart (Vmax Encore, SensorMedics, Yoba Linda, CA).
次要结局
- Cardiac Function and Structure at Rest(Baseline and 12 weeks.)
- Cardiovascular Risk Profile(Baseline and 12 weeks)
- Cardiac Function During Stress (Exercise)(Baseline and 12 weeks)
- Endothelial Function(Baseline and 12 weeks)
- Arterial Stiffness(Baseline and 12 weeks)
- Autonomic Function(Baseline and 12 weeks)
- Quality of Life(Baseline and 12 weeks)